Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02856555 | Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis | PHASE2 | COMPLETED | 127 | — | — | Aug 8, 2016 | Jul 18, 2017 | Jul 24, 2020 | 36 | United States |
| NCT02891408 | Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function | PHASE1 | COMPLETED | 74 | — | — | Sep 23, 2016 | May 13, 2019 | Dec 17, 2020 | 5 | United States |
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).
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).
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).
%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).
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).
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).
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).
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).
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).
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).
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).
| Arm | Type | Description |
|---|---|---|
| Firsocostat 5 mg | EXPERIMENTAL | Participants will receive firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks. |
| Firsocostat 20 mg | EXPERIMENTAL | Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks. |
| Placebo | EXPERIMENTAL | Participants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks. |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| Name | Type | Description |
|---|---|---|
| Firsocostat | DRUG | Capsules orally once daily. |
| Placebo | DRUG | Placebo matched to firsocostat orally once daily. |
| Fenofibrate | DRUG | Tablet administered orally on Day 1 |
Key Inclusion Criteria: * Meets all of the following conditions: * A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD) * Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis * Screening magnetic resonance elastography (MRE) with liver...