Study to Evaluate the Safety, Tolerability, and Pharmacok... | NCT00635804 | Trialant
NCT00635804
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 5, 2018Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Hepatitis C
Interventions
MK-3281
Placebo to MK-3281
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT00635804
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3281-002
Secondary IDs
ID
Type
Description
Link
2008_507
Other Identifier
Merck Registration Number
2007-006245-40
EudraCT Number
Brief Title
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)
Official Title
A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Rising Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy Male Subjects and Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-3281 in Hepatitis C Infected Male Patients
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 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
Feb 19, 2008Actual
Primary Completion Date
Dec 22, 2009Actual
Completion Date
Dec 22, 2009Actual
First Submitted Date
Feb 28, 2008
First Submission Date that Met QC Criteria
Mar 7, 2008
First Posted Date
Mar 14, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 18, 2016
Results First Submitted that Met QC Criteria
Mar 31, 2016
Results First Posted Date
May 4, 2016Estimated
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
Aug 6, 2018
Last Update Posted Date
Sep 5, 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
Not provided
Is FDA Regulated Device
Not provided
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 study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days in HCV-infected male participants is sufficiently safe and well tolerated, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.
The results of this study will guide dose selection for future studies in both healthy participants and HCV-infected participants.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C
Keywords
Not provided
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pt 1: MK-3281 100 mg BID (Panel A)
Experimental
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
Drug: MK-3281
Pt 1: MK-3281 200 mg BID (Panel B)
Experimental
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
Drug: MK-3281
Pt 1: MK-3281 400 mg BID (Panel C)
Experimental
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
Drug: MK-3281
Pt 1: MK-3281 800 mg BID (Panel D)
Experimental
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
Drug: MK-3281
Pt 2: MK-3281 800 mg BID (Panel E)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-3281
Drug
MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
Up to 14 days after the last dose of study drug (up to 24 days maximum)
Number of Participants Who Discontinued Study Medication Due to AEs
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
Up to 14 days after the last dose of study drug (up to 24 days maximum)
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281
Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Participant has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Participants with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Participant has a clinical diagnosis of chronic HCV infection (for Part II only).
Exclusion Criteria:
Participant has a history of stroke, chronic seizures, or major neurological disorder
Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Participant has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
Participant has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit
For Healthy Panel (Part I), participant has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit
Participant has a history of documented Human Immunodeficiency Virus (HIV) infection
60 participants were enrolled in this study and received MK-3281 or placebo in Panels A through G.
Recruitment Details
Panel H, planned for GT1a/GT1b HCV-infected male participants to receive 400 mg MK-3281 orally BID for 7 consecutive days, did not enroll any participants. As pre-specified by the protocol, it was possible that some panels would not be enrolled if study objectives were met with prior doses.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
FG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
FG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
FG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
FG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
FG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
FG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
FG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0007 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG00512 subjects
FG0063 subjects
FG00714 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
BG001
Pt 1: MK-3281 200 mg BID (Panel B)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Number of Participants Experiencing Adverse Events (AEs)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
All Treated Participants
Posted
Number
participants
Up to 14 days after the last dose of study drug (up to 24 days maximum)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 14 days after the last dose of study drug (up to 24 days maximum)
Description
AEs were reported for All Treated Participants.
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
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
Drug: MK-3281
Pt 2: MK-3281 800 mg BID (Panel F)
Experimental
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
Drug: MK-3281
Pt 2: MK-3281 1200 mg BID (Panel G)
Experimental
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
Drug: MK-3281
Placebo
Placebo Comparator
Participants receive dose-matched placebo to MK-3281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Drug: Placebo to MK-3281
Pt 1: MK-3281 100 mg BID (Panel A)
Pt 1: MK-3281 200 mg BID (Panel B)
Pt 1: MK-3281 400 mg BID (Panel C)
Pt 1: MK-3281 800 mg BID (Panel D)
Pt 2: MK-3281 1200 mg BID (Panel G)
Pt 2: MK-3281 800 mg BID (Panel E)
Pt 2: MK-3281 800 mg BID (Panel F)
Placebo to MK-3281
Drug
Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose of MK-3281 in serial panel. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Placebo
Maximum Plasma Concentration (Cmax) of MK-3281
Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
12-Hour Concentration of MK-3281 in Plasma (C12hr)
Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
Time To Reach Cmax (Tmax) of MK-3281
Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
Apparent Half-Life (t ½) of MK-3281
Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)
AUC (0-12hr) Accumulation Ratio of MK-3281
Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
Cmax Accumulation Ratio of MK-3281
Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
C12hr Accumulation Ratio of MK-3281
Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days
For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was calculated at each time point. The response for that participant was defined as: - (postbaseline time point - baseline) at the time point with the lowest HCV RNA level.
Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
6 subjects
FG00511 subjects
FG0063 subjects
FG00714 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
BG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
BG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
BG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
BG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
BG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
BG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
BG008
Total
Total of all reporting groups
7
BG0016
BG0026
BG0036
BG0046
BG00512
BG0063
BG00714
BG00860
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00037.1± 8.7
BG00136.3± 13.5
BG00237.0± 13.0
BG00334.0± 14.9
BG00439.2± 7.3
BG00547.5± 8.8
BG00645.0± 5.2
BG00739.4± 10.0
BG00839.9± 10.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Male
BG0007
BG0016
BG0026
BG0036
BG004
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0007
OG0016
OG0026
OG0036
OG0046
OG00512
OG0063
OG00714
Title
Denominators
Categories
Title
Measurements
OG0005
OG0013
OG0024
OG0035
OG0043
OG00512
OG0062
OG00712
Primary
Number of Participants Who Discontinued Study Medication Due to AEs
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
All Treated Participants
Posted
Number
participants
Up to 14 days after the last dose of study drug (up to 24 days maximum)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0007
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281
Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
μM·hr
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004.92± 39.9
OG00112.39± 36.2
OG00213.21± 45.0
OG003
Secondary
Maximum Plasma Concentration (Cmax) of MK-3281
Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
μM
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.74± 32.6
OG0011.75± 39.1
OG0021.80± 48.3
OG003
Secondary
12-Hour Concentration of MK-3281 in Plasma (C12hr)
Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
μM
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.26± 42.3
OG0010.61± 35.2
OG0020.70± 40.5
OG003
Secondary
Time To Reach Cmax (Tmax) of MK-3281
Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Median
Full Range
hour
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0003.0± 42.3(1.5 to 6.0)
OG0012.0± 35.2(1.5 to 3.0)
OG0025.0± 40.5(3.0 to 6.0)
Secondary
Apparent Half-Life (t ½) of MK-3281
Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Mean
Standard Deviation
hour
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 7
Title
Measurements
OG000NA± NAThis group was not assessed for PK on this day.
OG001NA± NAThis group was not assessed for PK on this day.
OG002NA± NA
Secondary
AUC (0-12hr) Accumulation Ratio of MK-3281
Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Geometric Mean
90% Confidence Interval
ratio
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.3± NA(1.6 to 3.4)
OG0012.4± NA(1.6 to 3.5)
OG0022.8± NA(1.9 to 4.1)
Secondary
Cmax Accumulation Ratio of MK-3281
Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Geometric Mean
90% Confidence Interval
ratio
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.7± NA(1.2 to 2.6)
OG0012.0± NA(1.3 to 3.0)
OG0022.8± NA(1.8 to 4.2)
Secondary
C12hr Accumulation Ratio of MK-3281
Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.
All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.
Posted
Geometric Mean
90% Confidence Interval
ratio
Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.5± NA(1.6 to 4.1)
OG0012.7± NA(1.7 to 4.4)
OG0022.6± NA(1.6 to 4.3)
Secondary
Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days
For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was calculated at each time point. The response for that participant was defined as: - (postbaseline time point - baseline) at the time point with the lowest HCV RNA level.
Treated HCV+ participants in Part II with available HCV RNA data. 800 mg dose group contained members of Panels E and F. No healthy participants from Part 1 (Panels A, B, C, or D) were assessed for this outcome measure.
Posted
Mean
95% Confidence Interval
log(IU/ml)
Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
ID
Title
Description
OG000
Pt 1: MK-3281 100 mg BID (Panel A)
Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
OG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
OG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
OG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
OG004
Pt 2: MK-3281 800 mg BID (Panels E+F)
GT1/GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
OG005
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
OG006
Placebo
HCV-infected participants in Part II who received dose-matched placebo to MK-03281 orally BID for 7 consecutive days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0041.95(1.36 to 2.54)
OG0051.34(-0.34 to 3.01)
OG0060.37(0.20 to 0.54)
0
7
5
7
EG001
Pt 1: MK-3281 200 mg BID (Panel B)
Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
0
6
3
6
EG002
Pt 1: MK-3281 400 mg BID (Panel C)
Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
0
6
4
6
EG003
Pt 1: MK-3281 800 mg BID (Panel D)
Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
0
6
5
6
EG004
Pt 2: MK-3281 800 mg BID (Panel E)
Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
0
6
3
6
EG005
Pt 2: MK-3281 800 mg BID (Panel F)
GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
0
12
12
12
EG006
Pt 2: MK-3281 1200 mg BID (Panel G)
GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
0
3
2
3
EG007
Placebo
Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
0
14
12
14
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Constipation
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Dental caries
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected12 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected14 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Flatulence
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Application site irritation
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected14 at risk
Catheter site haematoma
General disorders
MedDRA 13.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Catheter site inflammation
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Chest discomfort
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected14 at risk
Device breakage
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Fatigue
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0053 events3 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Malaise
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Vessel puncture site haematoma
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Gastroenteritis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected14 at risk
Oral herpes
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Rash pustular
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Procedural complication
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Alanine aminotransferase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Blood pressure increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Neutrophil count decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0003 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected14 at risk
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0042 events1 affected6 at risk
EG0055 events4 affected12 at risk
EG0060 events0 affected3 at risk
EG0073 events3 affected14 at risk
Migraine
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0046 events1 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Myoclonus
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Presyncope
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Loss of libido
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events2 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Restlessness
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Stress
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected14 at risk
Heat rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Haematoma
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Hot flush
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
Phlebitis
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected14 at risk
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
6
BG00512
BG0063
BG00714
BG00860
6
OG0046
OG00512
OG0063
OG00714
0
OG0040
OG0051
OG0060
OG0070
6
OG0046
OG00512
OG0063
OG0070
18.12
± 70.9
OG00412.78± 22.4
OG00511.36± 47.7
OG00612.01± 27.5
Day 7
Title
Measurements
OG000NA± NAThis group was not assessed for PK on this day.
OG001NA± NAThis group was not assessed for PK on this day.
OG002NA± NAThis group was not assessed for PK on this day.
OG003NA± NAThis group was not assessed for PK on this day.
OG00461.08± 20.1
OG00551.68± 29.8
OG00688.21± 37.0
Day 10
Title
Measurements
OG00011.51± 31.7
OG00129.71± 32.1
OG00237.21± 22.6
OG00367.11± 28.1
OG004NA± NAThis group did not receive MK-3281 on this day.
OG005NA± NAThis group did not receive MK-3281 on this day.
OG006NA± NAThis group did not receive MK-3281 on this day.
6
OG0046
OG00512
OG0063
OG0070
2.73
± 75.9
OG0041.61± 24.9
OG0051.60± 43.7
OG0061.69± 28.4
Day 7
Title
Measurements
OG000NA± NAThis group was not assessed for PK on this day.
OG001NA± NAThis group was not assessed for PK on this day.
OG002NA± NAThis group was not assessed for PK on this day.
OG003NA± NAThis group was not assessed for PK on this day.
OG0046.78± 23.9
OG0055.60± 33.3
OG00610.73± 40.5
Day 10
Title
Measurements
OG0001.28± 28.3
OG0013.45± 36.2
OG0024.97± 44.1
OG0037.83± 48.8
OG004NA± NAThis group did not receive MK-3281 on this day.
OG005NA± NAThis group did not receive MK-3281 on this day.
OG006NA± NAThis group did not receive MK-3281 on this day.
6
OG0046
OG00512
OG0063
OG0070
0.95
± 73.1
OG0040.76± 29.7
OG0050.64± 66.1
OG0060.64± 26.6
Day 7
Title
Measurements
OG000NA± NAThis group was not assessed for PK on this day.
OG001NA± NAThis group was not assessed for PK on this day.
OG002NA± NAThis group was not assessed for PK on this day.
OG003NA± NAThis group was not assessed for PK on this day.
OG0043.62± 25.7
OG0053.09± 26.9
OG0064.90± 32.1
Day 10
Title
Measurements
OG0000.64± 40.3
OG0011.66± 32.1
OG0021.86± 26.3
OG0032.87± 24.2
OG004NA± NAThis group did not receive MK-3281 on this day.
OG005NA± NAThis group did not receive MK-3281 on this day.
OG006NA± NAThis group did not receive MK-3281 on this day.
6
OG0046
OG00512
OG0063
OG0070
OG0033.0± 73.1(1.5 to 4.0)
OG0042.5± 29.7(1.4 to 4.0)
OG0053.0± 66.1(1.5 to 6.0)
OG0063.0± 26.6(3.0 to 3.1)
Day 7
Title
Measurements
OG000NA± NA(NA to NA)This group was not assessed for PK on this day.
OG001NA± NA(NA to NA)This group was not assessed for PK on this day.
OG002NA± NA(NA to NA)This group was not assessed for PK on this day.
OG003NA± NA(NA to NA)This group was not assessed for PK on this day.
OG0042.3± 25.7(0.0 to 2.8)
OG0052.0± 26.9(1.0 to 3.0)
OG0061.0± 32.1(0.0 to 1.5)
Day 10
Title
Measurements
OG0003.5± 40.3(2.0 to 4.0)
OG0013.0± 32.1(2.0 to 4.0)
OG0023.5± 26.3(1.5 to 6.0)
OG0033.0± 24.2(1.5 to 4.0)
OG004NA± NA(NA to NA)This group did not receive MK-3281 on this day.
OG005NA± NA(NA to NA)This group did not receive MK-3281 on this day.
OG006NA± NA(NA to NA)This group did not receive MK-3281 on this day.
6
OG0046
OG00512
OG0063
OG0070
This group was not assessed for PK on this day.
OG003NA± NAThis group was not assessed for PK on this day.
OG00418.3± 4.0
OG00519.7± 3.3
OG00619.5± 2.0
Day 10
Title
Measurements
OG00017.2± 2.3
OG00117.5± 2.9
OG00217.4± 2.5
OG00316.9± 1.3
OG004NA± NAThis group did not receive MK-3281 on Day 10, thus this day was not used to calculate t 1/2.
OG005NA± NAThis group did not receive MK-3281 on Day 10, thus this day was not used to calculate t 1/2.
OG006NA± NAThis group did not receive MK-3281 on Day 10, thus this day was not used to calculate t 1/2.