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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2018-08-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Hepatic Impairment

Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

100 mg tablet administered orally

Severe Hepatic Impairment

Participants with severe hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

100 mg tablet administered orally

Mild Hepatic Impairment

Participants with mild hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

100 mg tablet administered orally

Interventions

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Filgotinib

100 mg tablet administered orally

Intervention Type DRUG

Other Intervention Names

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GS-6034 GLPG0634

Eligibility Criteria

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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%).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes