Pharmacokinetics of GS-0976 or Fenofibrate in Adults With Normal and Impaired Hepatic Function



Status:Recruiting
Conditions:Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:3/30/2019
Start Date:September 23, 2016
End Date:May 2019
Contact:Gilead Study Team
Email:#gs-us-426-3988@gilead.com

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A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-0976 or Fenofibrate in Subjects With Normal and Impaired Hepatic Function

The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of
GS-0976 in adults with normal hepatic function, and mild, moderate, or severe hepatic
impairment and to evaluate the single-dose PK of fenofibrate in subjects with normal hepatic
function and mild hepatic impairment.


Key Inclusion Criteria:

Cohort 1 (Mild Hepatic Impairment):

- Male and non-pregnant/non-lactating females, ages 18-70 years inclusive 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, ages 18-70 years inclusive 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, ages 18-70 years inclusive 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, ages 18-70 years inclusive 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).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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