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



Status:Completed
Conditions:Arthritis, Colitis, Rheumatoid Arthritis, Gastrointestinal, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology, Rheumatology
Healthy:No
Age Range:18 - 70
Updated:10/18/2018
Start Date:April 3, 2018
End Date:August 9, 2018

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A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Filgotinib in Subjects With Impaired Hepatic Function

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.


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.
We found this trial at
3
sites
Miami, Florida 33014
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Miami, FL
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476 Landsberger Straße
Munich, 81241
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Munich,
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San Antonio, TX
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