Single and Multiple Dose Study of Uprifosbuvir (MK-3682/I... | NCT01974687 | Trialant
NCT01974687
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 13, 2018Actual
Enrollment
178Actual
Phase
Phase 1Phase 2
Conditions
Chronic Hepatitis C
Interventions
Uprifosbuvir
Placebo
Itraconazole
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01974687
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3682-001
Secondary IDs
ID
Type
Description
Link
U1111-1149-5611
Other Identifier
Universal Trial Number (UTN)
IDX-04B-001
Other Identifier
Idenix Protocol Number
2013-004043-23
EudraCT Number
MK-3682-001
Other Identifier
Merck Protocol Number
Brief Title
Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)
Official Title
A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 31, 2013Actual
Primary Completion Date
Sep 2, 2015Actual
Completion Date
Sep 11, 2015Actual
First Submitted Date
Oct 28, 2013
First Submission Date that Met QC Criteria
Oct 28, 2013
First Posted Date
Nov 1, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 4, 2017
Results First Submitted that Met QC Criteria
Sep 12, 2018
Results First Posted Date
Sep 13, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 12, 2018
Last Update Posted Date
Sep 13, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis C
Keywords
Hepatitis C virus
HCV
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
178Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A: Healthy
Experimental
Healthy participants will receive sequentially higher doses of uprifosbuvir (10 mg - 300 mg) capsules or matching placebo capsules once daily (QD) on Day 1 (Cohorts 1a-3a, 5a), Days 1 and 7 (Cohort 4a), or Day 1 - Day 7 (Cohort 6a). Dosing of next cohort will be based on review of available safety and PK data. Dosing will occur under fasted conditions with the exception of Cohort 4a, in which drug administration will occur under both fasted and fed conditions.
Drug: Uprifosbuvir
Drug: Placebo
Group B: GT1 HCV-infected, treatment naive on Day 1
Experimental
HCV GT1 participants with no prior direct-acting antiviral (DAA) exposure will receive a single dose of uprifosbuvir (10 mg - 300 mg) for 1 day across sequential dose cohorts. Dosing will commence following review of available safety and PK data from respective dose cohorts in Group A. All dosing will occur under fasted conditions.
Drug: Uprifosbuvir
Group C: GT1 HCV-infected on Days 1-7
Experimental
HCV GT1 participants will receive uprifosbuvir (50 mg - 400 mg in capsules or 300 mg or 450 mg in tablets) or matching placebo capsules QD for 7 days. Dosing will commence following review of available safety and PK data of Group A. Fed vs. fasted dosing will be dependent on food effect results from Group A.
Drug: Uprifosbuvir
Drug: Placebo
Group D: GT2 through GT6 HCV-infected on Days 1-7
Experimental
HCV GT2 - GT6 participants will receive uprifosbuvir (50 mg - 300 mg) capsules QD for 7 days. Dosing will commence following review of available safety and PK data from Group A. Fed vs. fasted dosing will be dependent on food effect results from Group A.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Uprifosbuvir
Drug
Uprifosbuvir 5 mg, 25 mg, or 50 mg capsule, or 150 mg tablet, administered by mouth.
Group A: Healthy
Group B: GT1 HCV-infected, treatment naive on Day 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study drug, and that does not necessarily have a causal relationship with the study drug(s). An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drug(s). The percentage of participants who experienced at least one AE is presented.
Up to 42 days
Percentage of Participants Who Experienced at Least One Treatment-emergent Serious AE (SAE)
An SAE was defined as any untoward medical occurrence that at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. The percentage of participants who experienced at least one SAE is presented.
Up to 42 days
Percentage of Participants Who Experienced a Treatment-emergent Dose-limiting Toxicity (DLT)
A DLT was defined as any of the following events: Any SAE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 clinical AE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 confirmed laboratory abnormalities considered by the investigator to be at least reasonably or possibly related to study drug, except for asymptomatic Grade ¾ cholesterol and triglyceride; Any clinical or laboratory AE of any intensity that is considered by the investigator to be at least reasonably or possibly related to study drug that necessitates permanent discontinuation of study drug; Confirmed increase in QT interval corrected for heart rate using Fridericia's (QTcF) formula ≥60 msec over Baseline or an absolute QTcF ≥500 msec.
Up to 13 days
Percentage of Participants Who Experienced at Least One Treatment-emergent Grade 1, 2, 3, 4 or 5 Laboratory Abnormality
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All Participants:
of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
must not have consumed grapefruit or grapefruit juice within 7 days of Day -1 and throughout the study
HCV Participants:
documented clinical history compatible with chronic hepatitis C.
have not received direct-acting antiviral treatment for hepatitis C infection
has HCV Genotype 1, 2, 3, 4, 5 or 6
Exclusion Criteria:
All Participants:
pregnant or breastfeeding
co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
decompensated liver disease
other clinically significant medical conditions or laboratory abnormalities.
Per protocol, the Group D part of the study allowed to randomize Genotype 2, 3, 4, 5 and 6 Hepatitis C Virus (HCV)-infected participants, however, only Genotype 2 and 3 HCV-infected participants were enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir (MK-3682/IDX21437) 10 mg as oral capsules under fasted conditions.
FG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Moldova
New Zealand
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Uprifosbuvir
Group E: GT1 HCV-infected on Days 1-7, mild hepatic impairment
Experimental
HCV GT1 participants with mildly impaired hepatic function will receive uprifosbuvir (150 mg - 450 mg) capsules QD for 1 or 7 days. Dosing of subsequent cohorts will be based on review of available safety and PK data. Fed vs. fasted dosing will be dependent on food effect results from Group A.
Drug: Uprifosbuvir
Group F: GT1 HCV-infected on Days 1-7, + Itraconazole
Experimental
HCV GT1 participants will receive itraconazole 200 mg twice daily (BID) on Day -5 and itraconazole 200 mg QD from Day -4 to Day 11. Participants will also be co-administered uprifosbuvir 300 mg from Day 1 to Day 7.
Drug: Itraconazole
Group C: GT1 HCV-infected on Days 1-7
Group D: GT2 through GT6 HCV-infected on Days 1-7
Group E: GT1 HCV-infected on Days 1-7, mild hepatic impairment
MK-3682/IDX21437
Placebo
Drug
Matching placebo to uprifosbuvir capsule administered by mouth.
Group A: Healthy
Group C: GT1 HCV-infected on Days 1-7
Itraconazole
Drug
Itraconazole is supplied as 10 mg/mL oral solution or 100 mg capsules administered by mouth.
Group F: GT1 HCV-infected on Days 1-7, + Itraconazole
Sporanox®
Laboratory abnormalities were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Treatment-emergent AEs (TEAEs)were graded as: Grade 1: Mild TEAE as Worst Severity; Grade 2: Moderate TEAE as Worst Severity; Grade 3: Severe TEAE as Worst Severity; Grade 4: Potentially Life-Threatening TEAE as Worst Severity; Grade 5: TEAE Leading to Death. The percentage of participants who experienced at least one Grade 1, 2, 3, 4 or 5 laboratory abnormality is presented.
Up to 42 days
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-emergent AE
The percentage of participants who discontinued study drug due to an AE is presented.
Up to 14 days
Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. All participants were fasted.
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Maximum observed plasma drug concentration was obtained. All participants were fasted.
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Maximum observed plasma drug concentration was obtained. All participants were fasted.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Maximum observed plasma drug concentration was obtained.
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Time to maximum plasma concentration was obtained. All participants were fasted.
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of Uprifosbuvir After Singe Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Time to maximum plasma concentration was obtained.
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Observed Terminal Half-Life (t1/2) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Area under the drug concentration-time curve from time zero to infinity for M6, a metabolite of uprifosbuvir, estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. All participants were fasted.
AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-inf of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Maximum observed plasma drug concentration was obtained. All participants were fasted.
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Maximum observed plasma drug concentration was obtained.
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Maximum observed plasma drug concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Time to maximum plasma concentration was obtained. All participants were fasted.
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Time to maximum plasma concentration was obtained.
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1,HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Time to maximum plasma concentration was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Cumulative Urine Excretion of Unchanged Uprifosbuvir in Healthy Participants (Group A)
Cumulative urine excretion of unchanged MK-3682 in healthy participants was obtained. All participants were fasted.
Reduction in HCV RNA From Baseline on Day 8 Following Uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-infected participants was obtained.
Baseline and Day 8
Maximum Reduction in log10 HCV RNA From Baseline - Normal Participants (From Groups B and C) vs. Mild Hepatic Impairment Participants (Group E)
Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype (Gt) 1, HCV-infected participants was obtained.
Baseline and 28 days after last dose of study drug (Up to 42 days)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
FG002
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
FG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
FG004
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
FG005
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
FG006
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
FG007
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
FG008
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
FG009
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
FG010
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
FG011
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
FG012
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
FG013
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
FG014
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
FG015
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
FG016
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
FG017
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
FG018
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
FG019
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
FG020
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
FG021
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
FG022
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
FG023
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
FG024
Group A: Placebo (Cohorts 1a-5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0042 subjects
FG0056 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
FG01113 subjects
FG01213 subjects
FG01310 subjects
FG01419 subjects
FG0159 subjects
FG0169 subjects
FG01711 subjects
FG0189 subjects
FG0193 subjects
FG0203 subjects
FG0218 subjects
FG0228 subjects
FG0236 subjects
FG02410 subjects
Treated
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0042 subjects
FG0056 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
FG01111 subjects2 participants discontinued prior to receiving study drug
FG01210 subjects3 participants discontinued prior to receiving study drug
FG0138 subjects2 participants discontinued prior to receiving study drug
FG01418 subjects1 participant discontinued prior to receiving study drug
FG0158 subjects1 participant discontinued prior to receiving study drug
FG0168 subjects1 participant discontinued prior to receiving study drug
FG0178 subjects3 participants discontinued prior to receiving study drug
FG0189 subjects
FG0193 subjects
FG0203 subjects
FG0218 subjects
FG0228 subjects
FG0236 subjects
FG02410 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0042 subjects
FG0056 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
FG01111 subjects
FG01210 subjects
FG0138 subjects
FG01418 subjects
FG0158 subjects
FG0168 subjects
FG0178 subjects
FG0189 subjects
FG0193 subjects
FG0203 subjects
FG0218 subjects
FG0228 subjects
FG0236 subjects
FG02410 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0123 subjects
FG0132 subjects
FG0141 subjects
FG0151 subjects
FG0161 subjects
FG0173 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
The baseline analysis population consisted of all participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
BG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
BG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
BG003
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
BG004
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
BG005
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
BG006
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
BG007
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
BG008
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
BG009
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
BG010
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
BG011
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
BG012
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
BG013
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
BG014
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
BG015
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
BG016
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
BG017
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
BG018
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
BG019
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
BG020
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
BG021
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
BG022
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
BG023
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
BG024
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
BG025
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0016
BG0026
BG0036
BG0046
BG0052
BG0066
BG0073
BG0083
BG0093
BG0103
BG0113
BG01211
BG01310
BG0148
BG01518
BG0168
BG0178
BG0188
BG0199
BG0203
BG0213
BG0228
BG0238
BG0246
BG025165
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00035.3± 7.72
BG00129.2± 7.36
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study drug, and that does not necessarily have a causal relationship with the study drug(s). An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drug(s). The percentage of participants who experienced at least one AE is presented.
Safety Population: all participants who received at least one dose of the study drug
Posted
Number
Percentage of Participants
Up to 42 days
ID
Title
Description
OG000
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
OG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG003
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
OG005
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG006
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG007
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
OG008
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG009
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG010
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG011
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG012
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG013
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG014
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG015
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
OG016
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG017
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
OG018
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG019
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG020
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
OG021
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG022
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG023
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG024
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG0010.0
OG00233.3
OG003
Primary
Percentage of Participants Who Experienced at Least One Treatment-emergent Serious AE (SAE)
An SAE was defined as any untoward medical occurrence that at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. The percentage of participants who experienced at least one SAE is presented.
Safety Population: all participants who received at least one dose of the study drug
Posted
Number
Percentage of Participants
Up to 42 days
ID
Title
Description
OG000
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
OG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Primary
Percentage of Participants Who Experienced a Treatment-emergent Dose-limiting Toxicity (DLT)
A DLT was defined as any of the following events: Any SAE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 clinical AE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 confirmed laboratory abnormalities considered by the investigator to be at least reasonably or possibly related to study drug, except for asymptomatic Grade ¾ cholesterol and triglyceride; Any clinical or laboratory AE of any intensity that is considered by the investigator to be at least reasonably or possibly related to study drug that necessitates permanent discontinuation of study drug; Confirmed increase in QT interval corrected for heart rate using Fridericia's (QTcF) formula ≥60 msec over Baseline or an absolute QTcF ≥500 msec.
Safety Population: all participants who received at least one dose of the study drug
Posted
Number
Percentage of Participants
Up to 13 days
ID
Title
Description
OG000
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
OG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Primary
Percentage of Participants Who Experienced at Least One Treatment-emergent Grade 1, 2, 3, 4 or 5 Laboratory Abnormality
Laboratory abnormalities were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Treatment-emergent AEs (TEAEs)were graded as: Grade 1: Mild TEAE as Worst Severity; Grade 2: Moderate TEAE as Worst Severity; Grade 3: Severe TEAE as Worst Severity; Grade 4: Potentially Life-Threatening TEAE as Worst Severity; Grade 5: TEAE Leading to Death. The percentage of participants who experienced at least one Grade 1, 2, 3, 4 or 5 laboratory abnormality is presented.
Safety Population: all participants who received at least one dose of the study drug
Posted
Number
Percentage of Participants
Up to 42 days
ID
Title
Description
OG000
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
OG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Primary
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-emergent AE
The percentage of participants who discontinued study drug due to an AE is presented.
Safety Population: all participants who received at least one dose of the study drug
Posted
Number
Percentage of Participants
Up to 14 days
ID
Title
Description
OG000
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
OG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG003
Primary
Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. All participants were fasted.
Pharmacokinetics (PK) Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Primary
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Primary
AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
Maximum (Peak) Observed Plasma Drug Concentration (Cmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Maximum observed plasma drug concentration was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG003
Primary
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Maximum observed plasma drug concentration was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
Time to Maximum Plasma Concentration (Tmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Time to maximum plasma concentration was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
Tmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
Tmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG003
Primary
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Tmax of Uprifosbuvir After Singe Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Primary
Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
Observed Terminal Half-Life (t1/2) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Primary
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Primary
t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Area under the drug concentration-time curve from time zero to infinity for M6, a metabolite of uprifosbuvir, estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Primary
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Primary
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Primary
AUC0-inf of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Primary
AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*umol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Maximum observed plasma drug concentration was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG003
Primary
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Cmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Maximum observed plasma drug concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Time to maximum plasma concentration was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG003
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Primary
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Tmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1,HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Time to maximum plasma concentration was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Median
Full Range
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Units
Counts
Participants
OG000
Primary
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG000
Primary
t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Primary
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group C: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG001
Group C: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Participants
Primary
t1/2 of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG000
Primary
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Units
Counts
Primary
t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
ID
Title
Description
OG000
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG000
Primary
Cumulative Urine Excretion of Unchanged Uprifosbuvir in Healthy Participants (Group A)
Cumulative urine excretion of unchanged MK-3682 in healthy participants was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
Cumulative Urine Excretion of Unchanged M6 in Healthy Participants (Group A)
Cumulative urine excretion of unchanged M6 in healthy participants was obtained. All participants were fasted.
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG001
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Primary
Reduction in HCV RNA From Baseline on Day 8 Following Uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-infected participants was obtained.
Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline and Day 8
ID
Title
Description
OG000
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG001
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Primary
Maximum Reduction in log10 HCV RNA From Baseline - Normal Participants (From Groups B and C) vs. Mild Hepatic Impairment Participants (Group E)
Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype (Gt) 1, HCV-infected participants was obtained.
Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline and 28 days after last dose of study drug (Up to 42 days)
ID
Title
Description
OG000
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG001
Group C: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG002
Group E: Uprifosbuvir 450 mg
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Time Frame
Up to 42 days (28 days after last study drug administration)
Description
Safety Population: participants who received at least one dose of the study drug. For Cohort 4a, serious AEs and nonserious AEs are presented for participants on the fasted regimen.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group A: Placebo (Cohort 1a - Cohort 5a - Pooled)
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
0
10
5
10
EG001
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
0
6
0
6
EG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
0
6
2
6
EG003
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
0
6
2
6
EG004
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
0
6
4
6
EG005
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
0
6
3
6
EG006
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
0
2
1
2
EG007
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
0
6
2
6
EG008
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
0
3
1
3
EG009
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
0
3
2
3
EG010
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
0
3
1
3
EG011
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
0
3
2
3
EG012
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
0
3
2
3
EG013
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
0
11
8
11
EG014
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
0
10
7
10
EG015
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
0
8
7
8
EG016
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
0
18
8
18
EG017
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
0
8
5
8
EG018
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
0
8
6
8
EG019
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
0
8
5
8
EG020
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
0
9
6
9
EG021
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
0
3
0
3
EG022
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
0
3
3
3
EG023
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
0
8
5
8
EG024
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
0
8
3
8
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected8 at risk
EG0160 events0 affected18 at risk
EG0170 events0 affected8 at risk
EG0180 events0 affected8 at risk
EG0191 events1 affected8 at risk
EG0200 events0 affected9 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected8 at risk
EG0240 events0 affected8 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Feeling cold
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site anaesthesia
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site reaction
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vulvitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Claustrophobia
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Breast enlargement
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Menstruation delayed
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatosis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin odour abnormal
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Institution and Investigator will submit any proposed publication to Sponsor for review and comment at least sixty (60) days prior to submission to a third party. If Sponsor believes in good faith that any proposed publication contains any proprietary or confidential information, Sponsor shall have the right to remove such references to such confidential information.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D019698
Hepatitis C, Chronic
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000627758
uprifosbuvir
D017964
Itraconazole
Ancestor Terms
ID
Term
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D010879
Piperazines
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
Between 18 and 65 years
BG00010
BG0016
BG0026
BG0036
BG0046
BG0052
BG0066
BG0073
BG0083
BG0093
BG0103
BG0113
BG01211
BG01310
BG0148
BG01518
BG0168
BG0178
BG0188
BG0199
BG0203
BG0213
BG0228
BG0238
BG0246
BG025165
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
33.3
± 15.06
BG00335.5± 11.76
BG00435.2± 9.87
BG00536.0± 2.83
BG00635.3± 12.69
BG00737.0± 9.54
BG00842.3± 7.23
BG00946.7± 4.16
BG01043.3± 5.69
BG01141.3± 8.96
BG01241.2± 10.68
BG01342.7± 10.37
BG01444.3± 8.63
BG01540.1± 11.69
BG01643.3± 8.45
BG01740.5± 11.70
BG01840.5± 8.94
BG01943.7± 7.68
BG02057.0± 4.36
BG02156.3± 3.06
BG02249.1± 8.04
BG02343.1± 12.54
BG02431.3± 11.60
BG02540.47± 10.85
2
BG0035
BG0044
BG0050
BG0064
BG0070
BG0080
BG0091
BG0102
BG0111
BG0125
BG0130
BG0145
BG0155
BG0163
BG0175
BG0184
BG0193
BG0200
BG0210
BG0221
BG0236
BG0243
BG02567
Male
BG0006
BG0012
BG0024
BG0031
BG0042
BG0052
BG0062
BG0073
BG0083
BG0092
BG0101
BG0112
BG0126
BG01310
BG0143
BG01513
BG0165
BG0173
BG0184
BG0196
BG0203
BG0213
BG0227
BG0232
BG0243
BG02598
6
OG0046
OG0056
OG0066
OG0072
OG0083
OG0093
OG0103
OG0113
OG0123
OG01311
OG01410
OG0158
OG01618
OG0178
OG0188
OG0198
OG0209
OG0213
OG0223
OG0238
OG0248
33.3
OG00466.7
OG00550.0
OG00633.3
OG00750.0
OG00833.3
OG00966.7
OG01033.3
OG01166.7
OG01266.7
OG01372.7
OG01470.0
OG01587.5
OG01644.4
OG01762.5
OG01875.0
OG01962.5
OG02066.7
OG0210.0
OG022100.0
OG02362.5
OG02437.5
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG003
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
OG005
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG006
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG007
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
OG008
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG009
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG010
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG011
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG012
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG013
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG014
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG015
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
OG016
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG017
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
OG018
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG019
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG020
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
OG021
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG022
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG023
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG024
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0072
OG0083
OG0093
OG0103
OG0113
OG0123
OG01311
OG01410
OG0158
OG01618
OG0178
OG0188
OG0198
OG0209
OG0213
OG0223
OG0238
OG0248
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
OG0100.0
OG0110.0
OG0120.0
OG0130.0
OG0140.0
OG0150.0
OG0160.0
OG0170.0
OG0180.0
OG0190.0
OG0200.0
OG0210.0
OG0220.0
OG0230.0
OG0240.0
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG003
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
OG005
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG006
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG007
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
OG008
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG009
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG010
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG011
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG012
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG013
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG014
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG015
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
OG016
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG017
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
OG018
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG019
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG020
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
OG021
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG022
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG023
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG024
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0072
OG0083
OG0093
OG0103
OG0113
OG0123
OG01311
OG01410
OG0158
OG01618
OG0178
OG0188
OG0198
OG0209
OG0213
OG0223
OG0238
OG0248
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
OG0100.0
OG0110.0
OG0120.0
OG0130.0
OG0140.0
OG0150.0
OG0160.0
OG0170.0
OG0180.0
OG0190.0
OG0200.0
OG0210.0
OG0220.0
OG0230.0
OG0240.0
OG002
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG003
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
OG005
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG006
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG007
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
OG008
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG009
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG010
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG011
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG012
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG013
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG014
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG015
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
OG016
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG017
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
OG018
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG019
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG020
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
OG021
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG022
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG023
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG024
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0072
OG0083
OG0093
OG0103
OG0113
OG0123
OG01311
OG01410
OG0158
OG01618
OG0178
OG0188
OG0198
OG0209
OG0213
OG0223
OG0238
OG0248
Title
Denominators
Categories
Grade 1
Title
Measurements
OG00050.00
OG0010.0
OG00216.7
OG00316.7
OG00450.0
OG00533.3
OG00633.3
OG00750.0
OG0080.0
OG00966.7
OG01033.3
OG01166.7
OG01266.7
OG01345.5
OG01460.0
OG01537.5
OG01633.3
OG0170.0
OG01837.5
OG01925.0
OG02033.3
OG0210.0
OG022100.0
OG02312.5
OG0240.0
Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG00216.7
OG003
Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Grade 5
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
OG005
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG006
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG007
Group A: Placebo (Cohort 6a)
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
OG008
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
OG009
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
OG010
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
OG011
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG012
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG013
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
OG014
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
OG015
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
OG016
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG017
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
OG018
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG019
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG020
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
OG021
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG022
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG023
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
OG024
Group F: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0072
OG0083
OG0093
OG0103
OG0113
OG0123
OG01311
OG01410
OG0158
OG01618
OG0178
OG0188
OG0198
OG0209
OG0213
OG0223
OG0238
OG0248
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
OG0100.0
OG0110.0
OG0120.0
OG0130.0
OG0140.0
OG0150.0
OG0160.0
OG0170.0
OG0180.0
OG0190.0
OG0200.0
OG0210.0
OG0220.0
OG0230.0
OG0240.0
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0000.0410± 32.7
OG0010.0837± 27.9
OG0021.67± 62.7
OG0032.78± 37.7
OG0040.246± 63.2
6
Title
Denominators
Categories
Title
Measurements
OG0001.05± 48.5
6
Title
Denominators
Categories
Day 1
Title
Measurements
OG0003.62± 34.0
Day 7
Title
Measurements
OG0003.77± 21.7
OG003
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG0000.0640± 39.8
OG0010.228± 49.1
OG0020.341± 20.4
OG0031.17± NANot calculated
OG0041.39± 35.4
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.394± 51.4
OG0011.01± 52.9
OG0022.80± 45.4
OG0035.54± 40.1
Day 7
Title
Measurements
OG0000.347± 36.2
OG0010.935± 36.7
OG0022.42± 46.8
OG003
OG0007
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002.00± 51.7
OG0013.11± 45.0
Day 7
Title
Measurements
OG0001.82± 43.9
OG0012.88± 30.4
2
Title
Denominators
Categories
Title
Measurements
OG0001.05± NANot calculated
Participants
OG0003
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0003.19± 32.8
OG0014.21± 35.2
Day 7
Title
Measurements
OG0002.31± 31.8
OG0013.51± 23.2
8
Title
Denominators
Categories
Day 1
Title
Measurements
OG00010.6± 44.0
Day 7
Title
Measurements
OG0009.39± 46.1
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG00029.6± 45.3
OG00147.7± 54.4
OG0021120± 47.8
OG0031530± 53.6
OG004119± 89.2
6
Title
Denominators
Categories
Title
Measurements
OG000293± 63.0
6
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002300± 26.6
Day 7
Title
Measurements
OG0002320± 19.9
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG00043.6± 60.7
OG001122± 26.4
OG002168± 11.4
OG003510± NANot calculated
OG004667± 15.3
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Day 1
Title
Measurements
OG000286± 77.1
OG001524± 80.1
OG0021360± 55.5
OG0032320± 50.2
Day 7
Title
Measurements
OG000199± 45.6
OG001587± 34.9
OG0021200± 59.4
OG003
OG0007
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG000618± 45.2
OG001778± 29.7
Day 7
Title
Measurements
OG000537± 56.4
OG001717± 47.2
2
Title
Denominators
Categories
Title
Measurements
OG000613± NANot calculated
OG0003
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001440± 35.9
OG0011090± 34.4
Day 7
Title
Measurements
OG0001550± 47.5
OG001929± 26.6
8
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002140± 39.4
Day 7
Title
Measurements
OG0001910± 42.6
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0000.80± 32.7(0.50 to 1.05)
OG0011.00± 27.9(0.50 to 3.00)
OG0020.76± 62.7(0.50 to 2.00)
OG0030.50± 37.7(0.50 to 2.00)
OG0041.00± 63.2(0.50 to 1.00)
6
Title
Denominators
Categories
Title
Measurements
OG0003.04± 47.8(3.00 to 4.05)
6
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.75± 26.6(0.50 to 1.00)
Day 7
Title
Measurements
OG0000.50± 19.9(0.50 to 2.03)
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG0000.50± 39.8(0.50 to 1.00)
OG0011.00± 49.1(0.53 to 1.00)
OG0021.00± 20.4(0.68 to 1.00)
OG0030.76± NA(0.52 to 1.00)
OG0041.00± 35.4(0.50 to 1.08)
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.85± 51.4(0.50 to 2.03)
OG0010.50± 52.9(0.50 to 2.00)
OG0021.00± 45.4(0.50 to 4.00)
OG0030.50± 40.1(0.50 to 2.00)
Day 7
Title
Measurements
OG0000.97± 36.2(0.50 to 1.00)
OG0010.50± 36.7(0.50 to 1.00)
OG0020.50± 46.8(0.48 to 3.00)
OG003
OG0007
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001.00± 51.7(0.50 to 4.00)
OG0012.00± 45.0(0.50 to 3.00)
Day 7
Title
Measurements
OG0000.50± 43.9(0.50 to 3.00)
OG0010.50± 30.4(0.50 to 3.00)
2
Title
Denominators
Categories
Title
Measurements
OG0000.75± NA(0.50 to 1.00)
Participants
OG0003
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001.00± 32.8(0.50 to 3.00)
OG0011.00± 35.2(0.50 to 2.00)
Day 7
Title
Measurements
OG0001.00± 31.8(0.50 to 1.00)
OG0011.00± 23.2(0.50 to 2.00)
8
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002.00± 44.0(1.00 to 3.00)
Day 7
Title
Measurements
OG0001.00± 46.1(1.00 to 3.00)
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0000.839± 27.3
OG0010.872± 33.7
OG0021.05± 25.0
OG0031.13± 31.6
OG0040.979± 36.6
6
Title
Denominators
Categories
Title
Measurements
OG0001.63± 31.9
OG003
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG0001.36± 52.7
OG0010.926± 34.5
OG0021.09± 32.5
OG0031.11± NANot calculated
OG0041.59± 1.7
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Title
Measurements
OG0001.04± 25.1
OG0011.11± 22.5
OG002154.± 34.0
OG0032.58± 40.3
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0002.50± 55.9
OG0013.64± 54.8
2
Title
Denominators
Categories
Title
Measurements
OG0001.16± NANot calculated
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG0001.18± 27.2
OG0012.38± 34.3
8
Title
Denominators
Categories
Title
Measurements
OG0004.30± 52.8
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0001.68± 47.4
OG0015.01± 27.2
OG00219.8± 12.7
OG00329.7± 32.1
OG0048.77± 8.4
6
Title
Denominators
Categories
Title
Measurements
OG00017.9± 13.4
6
Title
Denominators
Categories
Day 1
Title
Measurements
OG00015.1± 16.5
Day 7
Title
Measurements
OG00020.6± 17.9
OG003
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG0002.26± 22.3
OG0015.78± 4.7
OG0027.31± 11.1
OG00317.5± NANot calculated
OG00433.4± 37.0
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004.74± 37.6
OG0018.94± 20.2
OG00214.4± 20.8
OG00319.4± 11.1
Day 7
Title
Measurements
OG0007.12± 37.6
OG00112.2± 18.9
OG00219.0± 16.3
OG003
Participants
OG0007
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG00014.7± 36.6
OG00116.1± 23.5
Day 7
Title
Measurements
OG00021.4± 26.7
OG00124.7± 22.5
2
Title
Denominators
Categories
Title
Measurements
OG0001.05± NANot calculated
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG00013.4± 22.3
OG00118.4± 17.0
Day 7
Title
Measurements
OG00017.5± 23.5
OG00126.1± 26.5
8
Title
Denominators
Categories
Day 1
Title
Measurements
OG00013.2± 32.0
Day 7
Title
Measurements
OG00023.8± 37.0
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG00063.2± 19.8
OG001146± 13.6
OG002758± 28.2
OG0031190± 16.6
OG004283± 14.7
6
Title
Denominators
Categories
Title
Measurements
OG000509± 8.4
6
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001310± 7.5
Day 7
Title
Measurements
OG0001630± 14.9
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG00055.0± 15.0
OG001170± 7.2
OG002279± 5.2
OG003710± NANot calculated
OG0041210± 33.8
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Day 1
Title
Measurements
OG000298± 34.2
OG001641± 7.6
OG0021130± 22.7
OG0031560± 18.9
Day 7
Title
Measurements
OG000471± 33.7
OG001931± 14.4
OG0021420± 15.3
OG003
OG0007
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001010± 31.5
OG0011210± 21.9
Day 7
Title
Measurements
OG0001420± 23.2
OG0011680± 21.5
2
Title
Denominators
Categories
Title
Measurements
OG000597± NANot calculated
OG0003
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0001100± 11.5
OG0011180± 11.9
Day 7
Title
Measurements
OG0001550± 11.4
OG0011740± 19.7
8
Title
Denominators
Categories
Day 1
Title
Measurements
OG000738± 31.7
Day 7
Title
Measurements
OG0001180± 33.2
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0003.01± 32.7(2.00 to 6.00)
OG0013.50± 27.9(2.00 to 4.05)
OG0022.53± 62.7(2.00 to 6.05)
OG0033.50± 37.7(3.00 to 4.00)
OG0044.00± 63.2(2.00 to 6.00)
6
Title
Denominators
Categories
Title
Measurements
OG0006.00± 48.5(6.00 to 8.00)
6
Title
Denominators
Categories
Day 1
Title
Measurements
OG0003.00± 3.77(2.00 to 3.05)
Day 7
Title
Measurements
OG0002.50± 21.7(1.00 to 4.00)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG0004.00± 39.8(4.00 to 6.00)
OG0014.00± 49.1(3.03 to 4.00)
OG0022.05± 20.4(2.00 to 4.00)
OG0033.52± NA(3.03 to 4.00)
OG0044.00± 35.4(1.00 to 6.00)
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004.00± 51.4(1.00 to 8.00)
OG0013.00± 52.9(0.98 to 4.00)
OG0023.00± 45.4(2.00 to 6.00)
OG0034.00± 40.1(3.00 to 6.00)
Day 7
Title
Measurements
OG0002.00± 36.2(1.92 to 6.00)
OG0012.00± 36.7(1.00 to 3.00)
OG0023.00± 46.8(1.00 to 4.00)
OG003
OG0007
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004.00± 51.7(2.00 to 6.00)
OG0014.00± 45.0(3.00 to 6.03)
Day 7
Title
Measurements
OG0004.00± 43.9(2.00 to 4.00)
OG0014.00± 30.4(3.00 to 6.00)
2
Title
Denominators
Categories
Title
Measurements
OG0004.00± NA(4.00 to 4.00)
OG0003
OG0017
Title
Denominators
Categories
Day 1
Title
Measurements
OG0003.00± 32.8(2.00 to 4.00)
OG0014.00± 35.2(3.00 to 4.00)
Day 7
Title
Measurements
OG0002.00± 31.8(2.00 to 4.00)
OG0014.00± 23.2(2.00 to 4.00)
8
Title
Denominators
Categories
Day 1
Title
Measurements
OG00010.00± 44.0(6.00 to 23.5)
Day 7
Title
Measurements
OG0004.00± 46.1(3.00 to 8.00)
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG00022.5± 6.2
OG00124.6± 12.8
OG00229.1± 15.5
OG00328.8± 14.2
OG00422.9± 14.0
6
Title
Denominators
Categories
Title
Measurements
OG00027.1± 9.1
6
Title
Denominators
Categories
Title
Measurements
OG00032.2± 10.3
OG003
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
OG004
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0032
OG0043
Title
Denominators
Categories
Title
Measurements
OG00020.1± 3.4
OG00121.2± 4.8
OG00221.7± 19.8
OG00326.9± NANot calculated
OG00428.0± 12.1
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Units
Counts
Participants
OG00010
OG0019
OG00217
OG0037
Title
Denominators
Categories
Title
Measurements
OG00025.5± 16.8
OG00128.9± 15.2
OG00232.6± 12.7
OG00335.8± 17.8
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG00032.4± 7.7
OG00130.8± 26.8
2
Title
Denominators
Categories
Title
Measurements
OG00024.0± NANot calculated
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG00027.5± 9.3
OG00126.2± 24.8
8
Title
Denominators
Categories
Title
Measurements
OG00038.9± 17.7
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0000.280± 0.0800
OG0010.586± 0.164
OG0027.73± 4.67
OG00313.1± 4.16
OG0041.56± 0.397
OG003
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
OG004
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0005.93± 1.42
OG00115.2± 2.50
OG002101± 6.86
OG003200± 37.9
OG00431.8± 5.69
OG003
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
OG004
Groups C & D: Placebo (Pooled)
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
OG005
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
OG006
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.