Study in Healthy Volunteers to Evaluate the Safety, Toler... | NCT02654002 | Trialant
NCT02654002
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Oct 12, 2020Actual
Enrollment
120Actual
Phase
Phase 1
Conditions
Nonalcoholic Steatohepatitis (NASH)
Interventions
Cilofexor
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02654002
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-402-1851
Secondary IDs
Not provided
Brief Title
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Official Title
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Sep 2020
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
Jan 20, 2016Actual
Primary Completion Date
Jul 14, 2016Actual
Completion Date
Jul 14, 2016Actual
First Submitted Date
Jan 11, 2016
First Submission Date that Met QC Criteria
Jan 11, 2016
First Posted Date
Jan 13, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 16, 2020
Results First Submitted that Met QC Criteria
Sep 16, 2020
Results First Posted Date
Oct 12, 2020Actual
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 16, 2020
Last Update Posted Date
Oct 12, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
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 study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo.
Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated.
This study is partially blinded (no one is blinded on Day -1).
Detailed Description
Not provided
Conditions Module
Conditions
Nonalcoholic Steatohepatitis (NASH)
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
120Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Cilofexor 10 mg
Experimental
Participants in fasted state will receive cilofexor 10 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg or placebo once daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 2: Cilofexor 30 mg
Experimental
Participants in fasted state will receive cilofexor 30 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg or placebo once daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 3: Cilofexor 100 mg
Experimental
Participants in fasted state will receive cilofexor 100 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg or placebo once daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 4: Cilofexor 300 mg
Experimental
Participants in fasted state will receive cilofexor 300 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg or placebo once daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 5: Cilofexor 100 mg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cilofexor
Drug
Tablets administered orally
Cohort 10: Cilofexor
Cohort 1: Cilofexor 10 mg
Cohort 2: Cilofexor 30 mg
Cohort 3: Cilofexor 100 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Secondary Outcomes
Measure
Description
Time Frame
Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio
AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.
Healthy male and non-pregnant, non-lactating female volunteers
Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m^2
Normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
Normal renal function (estimated glomerular filtration rate calculated using the Cockcroft-Gault equation ≥ 80 mL/min)
No significant medical history, and in good general health as determined by the investigator at screening evaluation performed no more than 28 days prior to the scheduled first dose.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
45 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
SeaView Research, Inc
Miami
Florida
United States
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Background
Djedjos CS, Kirby BJ, Billin A, Gosink J, Song Q, Srihari R, et al. Pharmacodynamic Effects of the Oral, Non-Steroidal Farnesoid X Receptor Agonist GS-9674 in Healthy Volunteers. The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2016 November 11-15; Boston MA United States.
Background
Kirby BJ, Djedjos CS, Birkeback J, Song Q, Grycz K, Weston J, et al. Evaluation of the Safety and Pharmacokinetics of the Oral, Nonsteroidal Farnesoid X Receptor Agonist GS-9674 in Healthy Volunteers. The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2016 November 11-15; Boston MA United States.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
183 participants were screened. No participants were enrolled in Cohorts 9 and 10.
Recruitment Details
Participants were enrolled at one study site in the United States. The first participant was screened on 20 January 2016. The last study visit occurred on 14 July 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Cilofexor 10 mg
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
FG001
Cohort 2: Cilofexor 30 mg
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
5
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
Not provided
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
Participants in fed state will receive cilofexor 100 mg or placebo once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg or placebo tablet, orally, once daily with food from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 6: Cilofexor 50 mg
Experimental
Participants in fed state will receive cilofexor 50 mg or placebo twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg or placebo twice daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 7: Cilofexor 15 mg
Experimental
Participants in fed state will receive cilofexor 15 mg or placebo twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg or placebo twice daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 8: Cilofexor 10 mg
Experimental
Participants in fed state will receive cilofexor 10 mg or placebo once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg or placebo once daily from Day 7 to Day 20.
Drug: Cilofexor
Drug: Placebo
Cohort 9: Cilofexor
Experimental
Participants will receive cilofexor up to 300 mg or placebo once daily in the evening on empty stomach.
Drug: Cilofexor
Drug: Placebo
Cohort 10: Cilofexor
Experimental
Participants will receive cilofexor up to 300 mg or placebo once daily in the evening on empty stomach.
Percentage of Participants With at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
First dose date up to last dose date (Maximum: 20 days) plus 30 days
Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Investigator determined the ECG findings were clinically significant.
First dose date up to last dose date (Maximum: 20 days) plus 30 days
Percentage of Participants With Clinical Laboratory Abnormalities
Treatment-emergent laboratory (Hematology, Chemistry, and Urinalysis) abnormalities were defined as values that increase at least one toxicity grade from baseline. Laboratory Abnormalities are graded by the investigator as Grade 1, 2, 3, or 4 according to the modified Gilead Sciences, Inc (GSI) Grading Scale. The most severe graded abnormality from all tests was counted for each participant. Data is only reported for those Grades reported in 1 or more participants.
First dose date up to last dose date (Maximum: 20 days) plus 30 days
PD Parameter: FGF19 Cmax Ratio
Cmax is defined as the maximum observed concentration of FGF19 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmax Day 1 /Cmax Day-1. The ratio reported for Day 20 is the Cmax Day 20 /Cmax Day-1.
PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio
AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.
Cmin is defined as the minimum observed concentration of C4 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmin Day 1 /Cmin Day-1. The ratio reported for Day 20 is the Cmin Day 20 /Cmin Day-1.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
FG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
FG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
FG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
FG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
FG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
FG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
FG008
All Placebo
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
FG00824 subjects
COMPLETED
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG00511 subjects
FG00611 subjects
FG00711 subjects
FG00824 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Cilofexor 10 mg
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
BG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
BG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
BG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
BG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
BG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
BG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
BG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
BG008
All Placebo
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00312
BG00412
BG00511
BG00612
BG00711
BG00824
BG009118
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00034± 6.5
BG00135± 8.9
BG00237± 6.1
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
Black
BG0001
BG0011
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00012
BG00112
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
Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
The PK Analysis Set included all randomized participants who took at least 1 dose of Cilofexor and had at least 1 non-missing post-dose concentration value reported by the PK laboratory for each corresponding analyte.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0001236.0± 384.65
OG0012450.6± 921.70
OG0027712.1± 7270.76
OG003
Primary
Single-Dose PK Parameter: AUCinf of Cilofexor
AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Participants in the PK Analysis Set were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Primary
Single-Dose PK Parameter: Cmax of Cilofexor
Cmax is defined as the maximum observed concentration of drug in plasma.
Participants in the PK Analysis Set were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Primary
Multiple-Dose PK Parameter: AUCtau of Cilofexor
AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Participants in the PK Analysis Set were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Primary
Multiple-Dose PK Parameter: Cmax of Cilofexor
Cmax is defined as the maximum observed concentration of drug in plasma.
Participants in the PK Analysis Set with available data were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Primary
Multiple-Dose PK Parameter: Ctau of Cilofexor
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Participants in the PK Analysis Set with available data were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Primary
Percentage of Participants With at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
Posted
Number
percentage of participants
First dose date up to last dose date (Maximum: 20 days) plus 30 days
ID
Title
Description
OG000
Cohort 1: Cilofexor 10 mg
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Primary
Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Investigator determined the ECG findings were clinically significant.
Participants in the Safety Analysis Set were analyzed. Participants were grouped according to the treatment they actually received.
Posted
Number
percentage of participants
First dose date up to last dose date (Maximum: 20 days) plus 30 days
ID
Title
Description
OG000
Cohort 1: Cilofexor 10 mg
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Primary
Percentage of Participants With Clinical Laboratory Abnormalities
Treatment-emergent laboratory (Hematology, Chemistry, and Urinalysis) abnormalities were defined as values that increase at least one toxicity grade from baseline. Laboratory Abnormalities are graded by the investigator as Grade 1, 2, 3, or 4 according to the modified Gilead Sciences, Inc (GSI) Grading Scale. The most severe graded abnormality from all tests was counted for each participant. Data is only reported for those Grades reported in 1 or more participants.
Participants in the Safety Analysis Set with available data were analyzed. Participants were grouped according to the treatment they actually received.
Posted
Number
percentage of participants
First dose date up to last dose date (Maximum: 20 days) plus 30 days
ID
Title
Description
OG000
Cohort 1: Cilofexor 10 mg
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Secondary
Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio
AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.
The PD Analysis Set included all randomized participants who received at least 1 dose of study drug and had the necessary baseline and on-study measurement to provide interpretable results for each respective PD parameter. Included participants with available data.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Secondary
PD Parameter: FGF19 Cmax Ratio
Cmax is defined as the maximum observed concentration of FGF19 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmax Day 1 /Cmax Day-1. The ratio reported for Day 20 is the Cmax Day 20 /Cmax Day-1.
Participants in the PD Analysis Set with available data were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Secondary
PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio
AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.
Participants in the PD Analysis Set with available data were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Secondary
PD Parameter: C4 Cmin Ratio
Cmin is defined as the minimum observed concentration of C4 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmin Day 1 /Cmin Day-1. The ratio reported for Day 20 is the Cmin Day 20 /Cmin Day-1.
Participants in the PD Analysis Set with available data were analyzed.
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
OG002
Cohort 3: Cilofexor 100 mg
Time Frame
First dose date up to last dose date (Maximum: 20 days) plus 30 days
Description
The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
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
Cohort 1: Cilofexor 10 mg
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
0
12
0
12
4
12
EG001
Cohort 2: Cilofexor 30 mg
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
0
12
0
12
3
12
EG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
0
12
0
12
4
12
EG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
0
12
0
12
3
12
EG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
0
12
0
12
5
12
EG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
0
11
0
11
3
11
EG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
0
12
0
12
9
12
EG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
0
11
0
11
2
11
EG008
All Placebo
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
0
24
0
24
6
24
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0042 affected12 at risk
EG0050 affected11 at risk
EG0060 affected12 at risk
EG0070 affected11 at risk
EG0080 affected24 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Transaminases increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected12 at risk
EG0021 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dysfunctional uterine bleeding
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 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
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Point of Contact
Title
Organization
Phone
Extension
Email
Gilead Clinical Study Information Center
Gilead Sciences
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
ID
Term
D065626
Non-alcoholic Fatty Liver Disease
Ancestor Terms
ID
Term
D005234
Fatty Liver
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000717094
cilofexor
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
32
± 8.7
BG00440± 4.6
BG00533± 7.4
BG00635± 6.0
BG00735± 7.1
BG00836± 6.7
BG00935± 7.1
5
BG0034
BG0045
BG0056
BG0067
BG0078
BG00814
BG00959
Male
BG0006
BG0018
BG0027
BG0038
BG0047
BG0055
BG0065
BG0073
BG00810
BG00959
11
BG00312
BG00412
BG00511
BG00612
BG00711
BG00824
BG009116
Not Hispanic or Latino
BG0001
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0092
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
2
BG0033
BG0042
BG0052
BG0061
BG0072
BG0082
BG00916
White
BG00011
BG00111
BG00210
BG0039
BG00410
BG0059
BG00611
BG0079
BG00822
BG009102
12
BG00312
BG00412
BG00511
BG00612
BG00711
BG00824
BG009118
12
OG00412
OG00511
OG00612
OG00711
12458.8
± 4223.12
OG0044979.5± 2039.07
OG0053091.4± 752.66
OG0061301.9± 388.51
OG007905.9± 210.24
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00612
OG00711
Title
Denominators
Categories
Title
Measurements
OG0001255.9± 382.37
OG0012473.4± 920.85
OG0027743.7± 7273.50
OG00312495.7± 4230.00
OG0045016.7± 2022.94
OG0053559.2± 1092.73
OG0061409.3± 428.33
OG007924.0± 216.60
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00612
OG00711
Title
Denominators
Categories
Title
Measurements
OG000304.2± 126.66
OG001580.2± 283.79
OG0022592.3± 3059.31
OG0033055.5± 2022.27
OG004927.6± 540.94
OG005665.9± 152.30
OG006340.2± 124.44
OG007209.8± 63.24
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00611
OG00711
Title
Denominators
Categories
Title
Measurements
OG0001284.9± 460.35
OG0012891.0± 680.10
OG0026719.4± 3980.90
OG0038486.0± 4139.86
OG0044182.7± 1956.03
OG0053698.3± 837.91
OG0061293.5± 250.95
OG007848.2± 213.82
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00611
OG00711
Title
Denominators
Categories
Title
Measurements
OG000322.2± 136.70
OG001717.5± 235.50
OG0022231.2± 1693.78
OG0032327.9± 1897.48
OG004818.7± 437.28
OG005697.8± 145.60
OG006290.4± 78.71
OG007187.0± 57.10
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00611
OG00711
Title
Denominators
Categories
Title
Measurements
OG0002.7± 1.53
OG0017.9± 3.97
OG00236.3± 15.44
OG00370.1± 39.46
OG00422.6± 8.44
OG005107.6± 84.58
OG00628.4± 14.13
OG0073.0± 1.54
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG008
All Placebo
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00612
OG00711
OG00824
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00125.0
OG00233.3
OG00325.0
OG00441.7
OG00527.3
OG00675.0
OG00718.2
OG00829.2
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG008
All Placebo
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then receive placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00612
OG00711
OG00824
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG005
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG006
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG007
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG008
All Placebo
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00511
OG00612
OG00711
OG00824
Title
Denominators
Categories
Activated Partial Thromboplastin Time: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG00511
ParticipantsOG00612
ParticipantsOG00711
ParticipantsOG00824
Title
Measurements
OG0000.0
OG0018.3
OG00216.7
OG003
Hemoglobin-Hypo: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Hemoglobin-Hypo: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Hemoglobin-Hypo: Grade 3
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
International Normalized Ratio: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Lymphocytes: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Platelets: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Alanine Aminotransferase: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Alanine Aminotransferase: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Alanine Aminotransferase: Grade 3
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Aspartate Aminotransferase: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Aspartate Aminotransferase: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Aspartate Aminotransferase: Grade 3
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Aspartate Aminotransferase: Grade 4
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Albumin Corrected Calcium-Hyper: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Gamma-Glutamyltransferase: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Gamma-Glutamyltransferase: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Low-Density Lipoprotein: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Low-Density Lipoprotein: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Phosphate-Hypo: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Phosphate-Hypo: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Amylase: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Amylase: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Glucose,Fasting-Hyper: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Glucose,Fasting-Hyper:Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Glucose,Non-Fasting-Hyper:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Glucose,Non-Fasting-Hyper:Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Glucose,Non-Fasting-Hypo:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Potassium-Hypo:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Sodium-Hyper:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Serum Sodium-Hypo:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Total Bilirubin-Hyper:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Total Cholesterol-Hyper:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Total Cholesterol-Hyper:Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Uric Acid-Hyper:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Uric Acid-Hypo:Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Occult Blood: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Occult Blood: Grade 2
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Occult Blood: Grade 3
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Urine Glucose: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Urine Protein: Grade 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
OG002
Cohort 3: Cilofexor 100 mg
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
All Fasted Placebo
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
OG005
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG006
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG007
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG008
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG009
All Fed Placebo
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00611
OG00712
OG00811
OG00912
Title
Denominators
Categories
Day 1/Day -1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG00512
ParticipantsOG00611
ParticipantsOG00712
ParticipantsOG00811
ParticipantsOG00912
Title
Measurements
OG0002.040(1.571 to 2.650)
OG0011.958(1.478 to 2.594)
OG0022.037(1.699 to 2.442)
OG003
Day 20/Day -1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
All Fasted Placebo
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
OG005
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG006
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG007
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG008
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG009
All Fed Placebo
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00611
OG00712
OG00811
OG00912
Title
Denominators
Categories
Day 1/Day -1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG00512
ParticipantsOG00611
ParticipantsOG00712
ParticipantsOG00811
ParticipantsOG00912
Title
Measurements
OG0002.217(1.667 to 2.949)
OG0012.084(1.468 to 2.957)
OG0022.259(1.742 to 2.930)
OG003
Day 20/Day -1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
All Fasted Placebo
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
OG005
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG006
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG007
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG008
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG009
All Fed Placebo
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00611
OG00712
OG00811
OG00912
Title
Denominators
Categories
Day 1/Day -1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG00512
ParticipantsOG00611
ParticipantsOG00712
ParticipantsOG00811
ParticipantsOG00912
Title
Measurements
OG0000.681(0.431 to 1.077)
OG0010.640(0.516 to 0.794)
OG0020.427(0.340 to 0.537)
OG003
Day 20/Day -1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
OG003
Cohort 4: Cilofexor 300 mg
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
OG004
All Fasted Placebo
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
OG005
Cohort 5: Cilofexor 100 mg
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
OG006
Cohort 6: Cilofexor 50 mg
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
OG007
Cohort 7: Cilofexor 15 mg
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
OG008
Cohort 8: Cilofexor 10 mg
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
OG009
All Fed Placebo
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.