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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Filgotinib

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Clinical Pharmacology of Miami
American Research Corporation at the Texas Liver Institute
APEX GmbH
Auckland Clinical Studies Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Moderate Hepatic Impairment

Severe Hepatic Impairment

Mild Hepatic Impairment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) Parameter: AUClast of Filgotinib

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

PK Parameter: AUClast of GS-829845

AUClast is defined as the concentration of drug from time zero to the last observable concentration. GS-829845 is the primary metabolite of filgotinib.

PK Parameter: AUCinf of Filgotinib

AUCinf is defined as the concentration of drug extrapolated to infinite time.

PK Parameter: AUCinf of GS-829845

AUCinf is defined as the concentration of drug extrapolated to infinite time. GS-829845 is the primary metabolite of filgotinib.

PK Parameter: Cmax of Filgotinib

Cmax is defined as the maximum observed concentration of drug.

PK Parameter: Cmax of GS-829845

Cmax is defined as the maximum observed concentration of drug. GS-829845 is the primary metabolite of filgotinib.

Secondary Outcome Measures

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events

Percentage of Participants Who Experienced Graded Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

Full Information

NCT ID

NCT03417778

First Posted

January 25, 2018

Last Updated

December 21, 2020

Sponsor

Gilead Sciences

Collaborators

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT03417778

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

April 3, 2018 (Actual)

Primary Completion Date

August 9, 2018 (Actual)

Study Completion Date

August 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

Collaborators

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 matched, healthy controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate Hepatic Impairment

Arm Type

Experimental

Arm Description

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

Arm Title

Severe Hepatic Impairment

Arm Type

Experimental

Arm Description

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

Arm Title

Mild Hepatic Impairment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Filgotinib

Other Intervention Name(s)

GS-6034, GLPG0634

Intervention Description

100 mg tablet administered orally

Primary Outcome Measure Information:

Title

Pharmacokinetic (PK) Parameter: AUClast of Filgotinib

Description

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Time Frame