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Completed

NCT Number: NCT03417778

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

APEX GmbH, Munich, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgotinib

Drug

100 mg tablet administered orally

Other names: GS-6034, GLPG0634

Primary outcomes

  1. Pharmacokinetic (PK) Parameter: AUClast of Filgotinib

    Time frame: 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

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

  2. PK Parameter: AUClast of GS-829845

    Time frame: 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

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

  3. PK Parameter: AUCinf of Filgotinib

    Time frame: 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

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

  4. PK Parameter: AUCinf of GS-829845

    Time frame: 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

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

  5. PK Parameter: Cmax of Filgotinib

    Time frame: 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

    Cmax is defined as the maximum observed concentration of drug.

  6. PK Parameter: Cmax of GS-829845

    Time frame: 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

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

Secondary outcomes

  1. Percentage of Participants Who Experienced Treatment-Emergent Adverse Events

    Time frame: Day 1 up to Day 31

  2. Percentage of Participants Who Experienced Graded Laboratory Abnormalities

    Time frame: Day 1 up to Day 31

    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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Lakefront Biotherapeutics NV

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2018
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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