study to evaluate the pharmacokinetics of firsocostat or fenofibrate in adults with normal and impaired hepatic function

Conditions: Nonalcoholic Steatohepatitis (NASH)

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.