Nonalcoholic Steatohepatitis (NASH)
Conditions
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).
Interventions
DRUGCilofexor
Tablets administered orally
DRUGPlacebo
Tablets administered orally
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Laboratory Abnormalities | First dose date up to last dose date (Maximum: 20 days) plus 30 days | 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. |
| Multiple-Dose PK Parameter: Cmax of Cilofexor | Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | Cmax is defined as the maximum observed concentration of drug in plasma. |
| Multiple-Dose PK Parameter: Ctau of Cilofexor | Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| Percentage of Participants With at Least One Adverse Event (AE) | First dose date up to last dose date (Maximum: 20 days) plus 30 days | 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. |
| Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | First dose date up to last dose date (Maximum: 20 days) plus 30 days | Investigator determined the ECG findings were clinically significant. |
| Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration. |
| Single-Dose PK Parameter: AUCinf of Cilofexor | Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time). |
| Single-Dose PK Parameter: Cmax of Cilofexor | Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | Cmax is defined as the maximum observed concentration of drug in plasma. |
| Multiple-Dose PK Parameter: AUCtau of Cilofexor | Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD Parameter: FGF19 Cmax Ratio | Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | 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 | Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | 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. |
| PD Parameter: C4 Cmin Ratio | Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | 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. |
| Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose | 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. |
Countries
United States
Participant flow
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.
Pre-assignment details
183 participants were screened. No participants were enrolled in Cohorts 9 and 10.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 11 |
| 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. | 12 |
| 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. | 11 |
| 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. | 24 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrew Consent | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Cilofexor 10 mg | Total | All Placebo | Cohort 8: Cilofexor 10 mg | Cohort 7: Cilofexor 15 mg | Cohort 6: Cilofexor 50 mg | Cohort 5: Cilofexor 100 mg | Cohort 4: Cilofexor 300 mg | Cohort 3: Cilofexor 100 mg | Cohort 2: Cilofexor 30 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 6.5 | 35 years STANDARD_DEVIATION 7.1 | 36 years STANDARD_DEVIATION 6.7 | 35 years STANDARD_DEVIATION 7.1 | 35 years STANDARD_DEVIATION 6 | 33 years STANDARD_DEVIATION 7.4 | 40 years STANDARD_DEVIATION 4.6 | 32 years STANDARD_DEVIATION 8.7 | 37 years STANDARD_DEVIATION 6.1 | 35 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 116 Participants | 24 Participants | 11 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants | 16 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 11 Participants | 102 Participants | 22 Participants | 9 Participants | 11 Participants | 9 Participants | 10 Participants | 9 Participants | 10 Participants | 11 Participants |
| Region of Enrollment United States | 12 participants | 118 participants | 24 participants | 11 participants | 12 participants | 11 participants | 12 participants | 12 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 6 Participants | 59 Participants | 14 Participants | 8 Participants | 7 Participants | 6 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 59 Participants | 10 Participants | 3 Participants | 5 Participants | 5 Participants | 7 Participants | 8 Participants | 7 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 12 | 0 / 11 | 0 / 24 |
| other Total, other adverse events | 4 / 12 | 3 / 12 | 4 / 12 | 3 / 12 | 5 / 12 | 3 / 11 | 9 / 12 | 2 / 11 | 6 / 24 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 12 | 0 / 11 | 0 / 24 |
Outcome results
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).
Time frame: Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 1284.9 h*ng/mL | Standard Deviation 460.35 |
| Cohort 2: Cilofexor 30 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 2891.0 h*ng/mL | Standard Deviation 680.1 |
| Cohort 3: Cilofexor 100 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 6719.4 h*ng/mL | Standard Deviation 3980.9 |
| Cohort 4: Cilofexor 300 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 8486.0 h*ng/mL | Standard Deviation 4139.86 |
| Cohort 5: Cilofexor 100 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 4182.7 h*ng/mL | Standard Deviation 1956.03 |
| Cohort 6: Cilofexor 50 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 3698.3 h*ng/mL | Standard Deviation 837.91 |
| Cohort 7: Cilofexor 15 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 1293.5 h*ng/mL | Standard Deviation 250.95 |
| Cohort 8: Cilofexor 10 mg | Multiple-Dose PK Parameter: AUCtau of Cilofexor | 848.2 h*ng/mL | Standard Deviation 213.82 |
Primary
Multiple-Dose PK Parameter: Cmax of Cilofexor
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PK Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 322.2 ng/mL | Standard Deviation 136.7 |
| Cohort 2: Cilofexor 30 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 717.5 ng/mL | Standard Deviation 235.5 |
| Cohort 3: Cilofexor 100 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 2231.2 ng/mL | Standard Deviation 1693.78 |
| Cohort 4: Cilofexor 300 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 2327.9 ng/mL | Standard Deviation 1897.48 |
| Cohort 5: Cilofexor 100 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 818.7 ng/mL | Standard Deviation 437.28 |
| Cohort 6: Cilofexor 50 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 697.8 ng/mL | Standard Deviation 145.6 |
| Cohort 7: Cilofexor 15 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 290.4 ng/mL | Standard Deviation 78.71 |
| Cohort 8: Cilofexor 10 mg | Multiple-Dose PK Parameter: Cmax of Cilofexor | 187.0 ng/mL | Standard Deviation 57.1 |
Primary
Multiple-Dose PK Parameter: Ctau of Cilofexor
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PK Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 2.7 ng/mL | Standard Deviation 1.53 |
| Cohort 2: Cilofexor 30 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 7.9 ng/mL | Standard Deviation 3.97 |
| Cohort 3: Cilofexor 100 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 36.3 ng/mL | Standard Deviation 15.44 |
| Cohort 4: Cilofexor 300 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 70.1 ng/mL | Standard Deviation 39.46 |
| Cohort 5: Cilofexor 100 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 22.6 ng/mL | Standard Deviation 8.44 |
| Cohort 6: Cilofexor 50 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 107.6 ng/mL | Standard Deviation 84.58 |
| Cohort 7: Cilofexor 15 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 28.4 ng/mL | Standard Deviation 14.13 |
| Cohort 8: Cilofexor 10 mg | Multiple-Dose PK Parameter: Ctau of Cilofexor | 3.0 ng/mL | Standard Deviation 1.54 |
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.
Time frame: First dose date up to last dose date (Maximum: 20 days) plus 30 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With at Least One Adverse Event (AE) | 33.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With at Least One Adverse Event (AE) | 25.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With at Least One Adverse Event (AE) | 33.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With at Least One Adverse Event (AE) | 25.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With at Least One Adverse Event (AE) | 41.7 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With at Least One Adverse Event (AE) | 27.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With at Least One Adverse Event (AE) | 75.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With at Least One Adverse Event (AE) | 18.2 percentage of participants |
| All Placebo | Percentage of Participants With at Least One Adverse Event (AE) | 29.2 percentage of participants |
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.
Time frame: First dose date up to last dose date (Maximum: 20 days) plus 30 days
Population: Participants in the Safety Analysis Set with available data were analyzed. Participants were grouped according to the treatment they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 16.7 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 16.7 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 8.3 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 8.3 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 8.3 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 25.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 8.3 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 8.3 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 16.7 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 16.7 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 16.7 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 25.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 25.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 8.3 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 0.0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 16.7 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 16.7 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 8.3 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 16.7 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 16.7 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 8.3 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 16.7 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 0.0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 16.7 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 25.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 16.7 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 58.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 25.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 16.7 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 8.3 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 9.1 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 36.4 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 9.1 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 18.2 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 18.2 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 9.1 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 27.3 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 18.2 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 25.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 25.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 18.2 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 50.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 16.7 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 25.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 16.7 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 8.3 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 18.2 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 27.3 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 27.3 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 9.1 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 18.2 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Protein: Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 2 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Total Bilirubin-Hyper:Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 1 | 12.5 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 1 | 8.3 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 3 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Urine Glucose: Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 3 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hypo:Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Sodium-Hyper:Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Low-Density Lipoprotein: Grade 2 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 2 | 12.5 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 2 | 8.3 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Amylase: Grade 2 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Potassium-Hypo:Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 3 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hypo:Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase: Grade 4 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Albumin Corrected Calcium-Hyper: Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper: Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 2 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Phosphate-Hypo: Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Hemoglobin-Hypo: Grade 1 | 29.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Non-Fasting-Hyper:Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Occult Blood: Grade 3 | 8.3 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Lymphocytes: Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hyper:Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Platelets: Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 2 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase: Grade 1 | 4.2 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Serum Glucose,Fasting-Hyper:Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Uric Acid-Hypo:Grade 1 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | International Normalized Ratio: Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Gamma-Glutamyltransferase: Grade 2 | 0.0 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Total Cholesterol-Hyper:Grade 1 | 12.5 percentage of participants |
| All Placebo | Percentage of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time: Grade 1 | 0.0 percentage of participants |
Primary
Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Investigator determined the ECG findings were clinically significant.
Time frame: First dose date up to last dose date (Maximum: 20 days) plus 30 days
Population: Participants in the Safety Analysis Set were analyzed. Participants were grouped according to the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Cilofexor 10 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 2: Cilofexor 30 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 3: Cilofexor 100 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 4: Cilofexor 300 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 5: Cilofexor 100 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 6: Cilofexor 50 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 7: Cilofexor 15 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| Cohort 8: Cilofexor 10 mg | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
| All Placebo | Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 0 percentage of participants |
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.
Time frame: Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 1236.0 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 384.65 |
| Cohort 2: Cilofexor 30 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 2450.6 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 921.7 |
| Cohort 3: Cilofexor 100 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 7712.1 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 7270.76 |
| Cohort 4: Cilofexor 300 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 12458.8 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 4223.12 |
| Cohort 5: Cilofexor 100 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 4979.5 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 2039.07 |
| Cohort 6: Cilofexor 50 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 3091.4 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 752.66 |
| Cohort 7: Cilofexor 15 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 1301.9 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 388.51 |
| Cohort 8: Cilofexor 10 mg | Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | 905.9 hours*nanogram/millilitre (h*ng/mL) | Standard Deviation 210.24 |
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).
Time frame: Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 1255.9 h*ng/mL | Standard Deviation 382.37 |
| Cohort 2: Cilofexor 30 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 2473.4 h*ng/mL | Standard Deviation 920.85 |
| Cohort 3: Cilofexor 100 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 7743.7 h*ng/mL | Standard Deviation 7273.5 |
| Cohort 4: Cilofexor 300 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 12495.7 h*ng/mL | Standard Deviation 4230 |
| Cohort 5: Cilofexor 100 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 5016.7 h*ng/mL | Standard Deviation 2022.94 |
| Cohort 6: Cilofexor 50 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 3559.2 h*ng/mL | Standard Deviation 1092.73 |
| Cohort 7: Cilofexor 15 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 1409.3 h*ng/mL | Standard Deviation 428.33 |
| Cohort 8: Cilofexor 10 mg | Single-Dose PK Parameter: AUCinf of Cilofexor | 924.0 h*ng/mL | Standard Deviation 216.6 |
Primary
Single-Dose PK Parameter: Cmax of Cilofexor
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PK Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 304.2 ng/mL | Standard Deviation 126.66 |
| Cohort 2: Cilofexor 30 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 580.2 ng/mL | Standard Deviation 283.79 |
| Cohort 3: Cilofexor 100 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 2592.3 ng/mL | Standard Deviation 3059.31 |
| Cohort 4: Cilofexor 300 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 3055.5 ng/mL | Standard Deviation 2022.27 |
| Cohort 5: Cilofexor 100 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 927.6 ng/mL | Standard Deviation 540.94 |
| Cohort 6: Cilofexor 50 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 665.9 ng/mL | Standard Deviation 152.3 |
| Cohort 7: Cilofexor 15 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 340.2 ng/mL | Standard Deviation 124.44 |
| Cohort 8: Cilofexor 10 mg | Single-Dose PK Parameter: Cmax of Cilofexor | 209.8 ng/mL | Standard Deviation 63.24 |
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.
Time frame: Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PD Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.681 ratio |
| Cohort 1: Cilofexor 10 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.661 ratio |
| Cohort 2: Cilofexor 30 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.640 ratio |
| Cohort 2: Cilofexor 30 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.382 ratio |
| Cohort 3: Cilofexor 100 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.427 ratio |
| Cohort 3: Cilofexor 100 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.495 ratio |
| Cohort 4: Cilofexor 300 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.347 ratio |
| Cohort 4: Cilofexor 300 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.325 ratio |
| Cohort 5: Cilofexor 100 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 1.213 ratio |
| Cohort 5: Cilofexor 100 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 1.147 ratio |
| Cohort 6: Cilofexor 50 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.621 ratio |
| Cohort 6: Cilofexor 50 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.837 ratio |
| Cohort 7: Cilofexor 15 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.173 ratio |
| Cohort 7: Cilofexor 15 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.653 ratio |
| Cohort 8: Cilofexor 10 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 0.863 ratio |
| Cohort 8: Cilofexor 10 mg | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.624 ratio |
| All Placebo | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 1.108 ratio |
| All Placebo | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.974 ratio |
| All Fed Placebo | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 1/Day -1 | 1.057 ratio |
| All Fed Placebo | PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio | Day 20/Day -1 | 0.843 ratio |
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.
Time frame: Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PD Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.715 ratio |
| Cohort 1: Cilofexor 10 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.822 ratio |
| Cohort 2: Cilofexor 30 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.759 ratio |
| Cohort 2: Cilofexor 30 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.456 ratio |
| Cohort 3: Cilofexor 100 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.663 ratio |
| Cohort 3: Cilofexor 100 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.624 ratio |
| Cohort 4: Cilofexor 300 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.467 ratio |
| Cohort 4: Cilofexor 300 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.432 ratio |
| Cohort 5: Cilofexor 100 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 1.262 ratio |
| Cohort 5: Cilofexor 100 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 1.201 ratio |
| Cohort 6: Cilofexor 50 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.440 ratio |
| Cohort 6: Cilofexor 50 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.613 ratio |
| Cohort 7: Cilofexor 15 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.116 ratio |
| Cohort 7: Cilofexor 15 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.348 ratio |
| Cohort 8: Cilofexor 10 mg | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.737 ratio |
| Cohort 8: Cilofexor 10 mg | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.508 ratio |
| All Placebo | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 0.961 ratio |
| All Placebo | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.862 ratio |
| All Fed Placebo | PD Parameter: C4 Cmin Ratio | Day 1/Day -1 | 1.162 ratio |
| All Fed Placebo | PD Parameter: C4 Cmin Ratio | Day 20/Day -1 | 0.983 ratio |
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.
Time frame: Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: Participants in the PD Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 2.217 ratio |
| Cohort 1: Cilofexor 10 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 2.157 ratio |
| Cohort 2: Cilofexor 30 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 2.084 ratio |
| Cohort 2: Cilofexor 30 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 2.393 ratio |
| Cohort 3: Cilofexor 100 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 2.259 ratio |
| Cohort 3: Cilofexor 100 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 2.325 ratio |
| Cohort 4: Cilofexor 300 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 2.679 ratio |
| Cohort 4: Cilofexor 300 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 3.084 ratio |
| Cohort 5: Cilofexor 100 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 1.210 ratio |
| Cohort 5: Cilofexor 100 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 0.982 ratio |
| Cohort 6: Cilofexor 50 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 2.241 ratio |
| Cohort 6: Cilofexor 50 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 2.793 ratio |
| Cohort 7: Cilofexor 15 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 2.455 ratio |
| Cohort 7: Cilofexor 15 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 2.973 ratio |
| Cohort 8: Cilofexor 10 mg | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 1.961 ratio |
| Cohort 8: Cilofexor 10 mg | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 1.768 ratio |
| All Placebo | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 1.689 ratio |
| All Placebo | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 1.878 ratio |
| All Fed Placebo | PD Parameter: FGF19 Cmax Ratio | Day 1/Day -1 | 0.929 ratio |
| All Fed Placebo | PD Parameter: FGF19 Cmax Ratio | Day 20/Day -1 | 0.874 ratio |
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.
Time frame: Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Cilofexor 10 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 2.040 ratio |
| Cohort 1: Cilofexor 10 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 2.270 ratio |
| Cohort 2: Cilofexor 30 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 1.958 ratio |
| Cohort 2: Cilofexor 30 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 2.261 ratio |
| Cohort 3: Cilofexor 100 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 2.037 ratio |
| Cohort 3: Cilofexor 100 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 2.054 ratio |
| Cohort 4: Cilofexor 300 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 2.314 ratio |
| Cohort 4: Cilofexor 300 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 2.179 ratio |
| Cohort 5: Cilofexor 100 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 1.249 ratio |
| Cohort 5: Cilofexor 100 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 0.981 ratio |
| Cohort 6: Cilofexor 50 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 1.795 ratio |
| Cohort 6: Cilofexor 50 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 2.406 ratio |
| Cohort 7: Cilofexor 15 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 2.119 ratio |
| Cohort 7: Cilofexor 15 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 2.629 ratio |
| Cohort 8: Cilofexor 10 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 1.743 ratio |
| Cohort 8: Cilofexor 10 mg | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 1.650 ratio |
| All Placebo | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 1.372 ratio |
| All Placebo | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 1.509 ratio |
| All Fed Placebo | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 1/Day -1 | 0.916 ratio |
| All Fed Placebo | Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio | Day 20/Day -1 | 0.963 ratio |