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

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)

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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