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

NCT03417778 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: GS-US-417-40482017-000156-25
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 4

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetic (PK) Parameter: AUClast of Filgotinib

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

  Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1

• 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.

  Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1

• PK Parameter: AUCinf of Filgotinib

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

  Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1

• 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.

  Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1

• PK Parameter: Cmax of Filgotinib

  Cmax is defined as the maximum observed concentration of drug.

  Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1

• PK Parameter: Cmax of GS-829845

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

  Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1

Secondary Outcomes (2)

• Percentage of Participants Who Experienced Treatment-Emergent Adverse Events

  Day 1 up to Day 31

• Percentage of Participants Who Experienced Graded Laboratory Abnormalities

  Day 1 up to Day 31

Study Arms (3)

Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: Filgotinib

Severe Hepatic Impairment

EXPERIMENTAL

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

Drug: Filgotinib

Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: Filgotinib

Interventions

Filgotinib DRUG

100 mg tablet administered orally

Also known as: GS-6034, GLPG0634

Mild Hepatic Impairment; Moderate Hepatic Impairment; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

Sponsors & Collaborators

• Gilead Sciences: lead
• Galapagos NV: collaborator

Study Sites (4)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

APEX GmbH

Munich, 81241, Germany

Location

Auckland Clinical Studies Ltd.

Grafton, Auckland, 1010, New Zealand

Location

Related Publications (1)

• Anderson K, Zheng H, Medzihradsky O, et al. THU0117 PHARMACOKINETICS AND SHORT-TERM SAFETY OF FILGOTINIB, A SELECTIVE JANUS KINASE 1 INHIBITOR, IN SUBJECTS WITH MODERATE HEPATIC IMPAIRMENT. Annals of the Rheumatic Diseases. 2019;78:331.

  RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: April 3, 2018
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: January 15, 2021
• Results First Posted: January 15, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); NZ (1); DE (1)