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

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Gilead Sciences

Status and phase

Completed
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Filgotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03417778
GS-US-417-4048
2017-000156-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 3 patient groups

Moderate Hepatic Impairment
Experimental group
Description:
Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.
Treatment:
Drug: Filgotinib
Severe Hepatic Impairment
Experimental group
Description:
Participants with severe hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.
Treatment:
Drug: Filgotinib
Mild Hepatic Impairment
Experimental group
Description:
Participants with mild hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.
Treatment:
Drug: Filgotinib

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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