Status:
COMPLETED
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
Galapagos NV
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03417778
Start Date
April 3 2018
End Date
August 9 2018
Last Update
January 15 2021
Active Locations (4)
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1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
2
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
3
APEX GmbH
Munich, Germany, 81241
4
Auckland Clinical Studies Ltd.
Grafton, Auckland, New Zealand, 1010