Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function

Gilead Sciences20 enrolled

Overview

The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic function relative to matched, healthy controls.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

FilgotinibDRUG

100 mg tablet administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Eligible individuals will be male and nonpregnant, nonlactating females, aged 18 to 70 years (inclusive), body mass index (BMI) between 18 and 36 kg/m\^2 (inclusive), with either impaired hepatic function or normal hepatic function. * Individuals will be current nonsmokers (no use of tobacco, nicotine-containing, or tetrahydrocannabinol \[THC\]-containing products within the last 14 days). * Individuals with hepatic impairment will be categorized by the Child-Pugh-Turcotte (CPT) classification system indicating hepatic impairment as follows: * Class A (mild): CPT score 5-6 * Class B (moderate): CPT score 7-9 * Class C (severe): CPT score 10-15 * Hepatic impairment must have been stable during the 3 months (90 days) prior to study drug. Each individual in the control group will be matched to a individual with impaired hepatic function by age (± 10 years), gender, and body mass index (± 15%). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (4)

Clinical Pharmacology of Miami

Miami, Florida, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

APEX GmbH

Munich, Germany

Auckland Clinical Studies Ltd.

Grafton, Auckland, New Zealand

Outcomes

Primary Outcomes

Pharmacokinetic (PK) Parameter: AUClast of Filgotinib

AUClast is defined as the concentration of drug from time zero to the last observable concentration.