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Keep this study
Lead
Gilead Sciences
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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).
Clareo Health | Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function