Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Firsocostat; Fenofibrate
Intervention description: Capsule(s) administered orally on Day 1; Tablet administered orally on Day 1
Intervention MeSH terms: Fenofibrate; Firsocostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Cohort 1 (Mild Hepatic Impairment):

          -  Male and non-pregnant/non-lactating females with mildly impaired and normal hepatic
             function.

          -  Individuals will be current non-smokers (no use of tobacco, nicotine-containing or
             tetrahydrocannabinol (THC)-containing products within the last 14 days).

          -  Each individual in the control group will be matched for age (± 10 years), gender,
             race, and body mass index (± 15% 18 ≤ body mass index (BMI) ≤ 36 kg/m^2) with an
             individual in the mild hepatic impairment group.

          -  Individuals with mild hepatic impairment must have a score of 5-6 on the
             Child-Pugh-Turcotte (CPT) Classification at screening, have diagnosis of chronic (> 6
             months), and stable hepatic impairment with no clinically significant changes within 3
             months (or 90 days) prior to study drug administration (Day 1).

        Cohort 2 (Moderate Hepatic Impairment):

          -  Male and non-pregnant/non-lactating females with moderately impaired and normal
             hepatic function.

          -  Individuals will be current non-smokers (no smoking of tobacco, nicotine-containing or
             THC-containing products within the last 14 days).

          -  Each individual in the control group will be matched for age (± 10 years), gender,
             race, and body mass index (± 15% 18 ≤ BMI ≤ 36 kg/m^2) with an individual in the
             moderate hepatic impairment group.

          -  Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT
             Classification at screening, have diagnosis of chronic (> 6 months), and stable
             hepatic impairment with no clinically significant changes within 3 months (or 90 days)
             prior to study drug administration (Day 1).

        Cohort 3 (Severe Hepatic Impairment):

          -  Male and nonpregnant/non-lactating females with severely impaired and normal hepatic
             function.

          -  Individuals will be current non-smokers (no use of tobacco, nicotine-containing or
             THC-containing products within the last 14 days).

          -  Each individual in the control group will be matched for age (± 10 years), gender,
             race, and body mass index (± 15% 18 ≤ BMI ≤ 36 kg/m^2) with an individual in the
             severe hepatic impairment group.

          -  Individuals with severe hepatic impairment must have a score of 10-15 on the CPT
             Classification at screening, have diagnosis of chronic (> 6 months), and stable
             hepatic impairment with no clinically significant changes within 3 months (or 90 days)
             prior to study drug administration (Day 1).

        Cohort 4 (Mild Hepatic Impairment):

          -  Male and non-pregnant/non-lactating females with mildly impaired and normal hepatic
             function.

          -  Individuals will be current non-smokers (no use of tobacco, nicotine-containing or
             THC-containing products within the last 14 days).

          -  Each individual in the control group will be matched for age (± 10 years), gender,
             race, and body mass index (± 15% 18 ≤ body mass index (BMI) ≤ 36 kg/m^2) with an
             individual in the mild hepatic impairment group.

          -  Individuals with mild hepatic impairment must have a score of 5-6 on the
             Child-Pugh-Turcotte (CPT) Classification at screening, have diagnosis of chronic (> 6
             months), and stable hepatic impairment with no clinically significant changes within 3
             months (or 90 days) prior to study drug administration (Day 1).

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.