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The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK of fenofibrate in adults with normal hepatic function and mild hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg | Experimental | Participants with mild hepatic impairment will receive a single dose of firsocostat 20 mg (2 × 10 mg capsules). |
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| Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg | Experimental | Matched normal hepatic function participants to mild hepatic impairment participants will receive a single dose of firsocostat 20 mg (2 × 10 mg capsules). |
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| Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg | Experimental | Participants with moderate hepatic impairment will receive a single dose of firsocostat 20 mg (2 × 10 mg capsules). |
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| Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Experimental | Matched normal hepatic function participants to moderate hepatic impairment participants will receive a single dose of firsocostat 20 mg (2 × 10 mg capsules). |
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| Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Experimental | Participants with severe hepatic impairment will receive a single dose of firsocostat 5 mg (1 × 5 mg capsule). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firsocostat | Drug | Capsule(s) administered orally on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: AUCinf of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | AUCinf is defined as the concentration of drug extrapolated to infinite time. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: Cmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Cmax is defined as the maximum observed concentration of drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: % AUCexp of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) | Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following:
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Key Inclusion Criteria:
Cohort 1 (Mild Hepatic Impairment):
Cohort 2 (Moderate Hepatic Impairment):
Cohort 3 (Severe Hepatic Impairment):
Cohort 4 (Mild Hepatic Impairment):
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tustin | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Nelson C, Weber E, Yue MS, Millward V, Qin AR, Marbury TC, et al. The Pharmacokinetics of GS-0976, an Acetyl-CoA Carboxylase (ACC) Inhibitor, in Subjects with Mild, Moderate, and Severe Hepatic Impairment [Abstract 1719]. Hepatology AASLD Abstracts 2018;68 (Suppl 1):979A-80A. |
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In the control groups (normal hepatic function), each participant was matched for age, gender, race, and body mass index with a participant in the hepatic impairment group. 14 total unique participants with normal hepatic function were enrolled in Cohort 1 (N = 10) and Cohort 2 (N = 4). 6 participants with normal hepatic function from Cohort 1 also served as matched controls in Cohort 2.
Participants were enrolled at study sites in United States. The first participant was screened on 23 September 2016. The last study visit occurred on 13 May 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg | Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| FG001 | Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2018 | Apr 3, 2020 |
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| Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg | Experimental | Matched normal hepatic function participants to severe hepatic impairment participants will receive a single dose of firsocostat 5 mg (1 × 5 mg capsule). |
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| Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Experimental | Participants with mild hepatic impairment will receive a single dose of fenofibrate 48 mg (1 × 48 mg tablet). |
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| Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg | Experimental | Matched normal hepatic function participants to mild hepatic impairment participants, will receive a single dose of fenofibrate 48 mg (1 × 48 mg tablet). |
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| Fenofibrate | Drug | Tablet administered orally on Day 1 |
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| Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: Tmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Tmax is defined as the time (observed time point) of Cmax. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: Clast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Clast is defined as the last observed quantifiable concentration of drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: Tlast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Tlast is defined as the time (observed time point) of Clast. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: λz of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: CL/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | CL/F is defined as the apparent oral clearance following administration of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: Vz/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Vz/F is defined as the apparent volume of distribution of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| PK Parameter: t1/2 of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
| First dose date plus 30 days |
| Percentage of Participants Experiencing Laboratory Abnormalities | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from predose at any postdose visit, up to and including the date of last dose of study drug plus 30 days for subjects who permanently discontinued study drug. The most severe graded abnormality from all tests was counted for each participant. | First dose date plus 30 days |
| Miami |
| Florida |
| United States |
| Orlando | Florida | United States |
| Minneapolis | Minnesota | United States |
| San Antonio | Texas | United States |
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| FG002 | Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1 |
| FG003 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| FG004 | Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| FG005 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| FG006 | Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg | Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| BG001 | Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg | Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| BG002 | Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1 |
| BG003 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| BG004 | Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| BG005 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| BG006 | Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | PK Analysis Sets included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by PK laboratory for corresponding analytes. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: AUCinf of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | AUCinf is defined as the concentration of drug extrapolated to infinite time. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: Cmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Cmax is defined as the maximum observed concentration of drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | ng/mL | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: % AUCexp of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | percentage of AUC | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: Tmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Tmax is defined as the time (observed time point) of Cmax. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Median | Inter-Quartile Range | hours | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: Clast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Clast is defined as the last observed quantifiable concentration of drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | ng/mL | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: Tlast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Tlast is defined as the time (observed time point) of Clast. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Median | Inter-Quartile Range | hours | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: λz of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | 1/hour | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: CL/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | CL/F is defined as the apparent oral clearance following administration of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | mL/hour | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: Vz/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Vz/F is defined as the apparent volume of distribution of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Mean | Standard Deviation | mL | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Primary | PK Parameter: t1/2 of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4). | Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2. | Posted | Median | Inter-Quartile Range | hours | Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable) |
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| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) | Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following:
| Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2. | Posted | Number | percentage of participants | First dose date plus 30 days |
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| Secondary | Percentage of Participants Experiencing Laboratory Abnormalities | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from predose at any postdose visit, up to and including the date of last dose of study drug plus 30 days for subjects who permanently discontinued study drug. The most severe graded abnormality from all tests was counted for each participant. | Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2. | Posted | Number | Percentage of participants | First dose date plus 30 days |
|
First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg | Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG001 | Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg | Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1 | 0 | 14 | 0 | 14 | 1 | 14 |
| EG003 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. | 0 | 10 | 0 | 10 | 3 | 10 |
| EG004 | Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG005 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG006 | Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. | 0 | 10 | 0 | 10 | 1 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2019 | Apr 3, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629250 | firsocostat |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| GS-834773 |
|
|
| Fenofibric Acid |
|
|
| GLSM ratio |
| 881 |
| 2-Sided |
| 90 |
| 488 |
| 1589 |
| Other |
| AUClast of Firsocostat | GLSM ratio | 3081 | 2-Sided | 90 | 2446 | 3881 | Other |
| AUClast of GS-834773 | GLSM ratio | 430 | 2-Sided | 90 | 185 | 998 | Other |
| AUClast of GS-834773 | GLSM ratio | 4417 | 2-Sided | 90 | 1867 | 10449 | Other |
| AUClast of GS-834773 | GLSM ratio | 14676 | 2-Sided | 90 | 7932 | 27153 | Other |
| AUClast of Fenofibric Acid | GLSM ratio | 122 | 2-Sided | 90 | 86 | 173 | Other |
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1 |
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
| OG003 | Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg | Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1. |
| OG004 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG006 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG007 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1 |
| OG003 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG004 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG006 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
|
|
| OG003 | Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg | Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG004 | Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg | Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1. |
| OG005 | Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg | Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
| OG006 | Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg | Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1. |
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