Phase 1
Completed N=20
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
Source: ClinicalTrials.gov NCT03417778 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Pharmacokinetic (PK) Parameter: AUClast of Filgotinib — 2389.3; 1981.9 h*ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: AUClast of Filgotinib |
2389.3; 1981.9 | — |
| PRIMARY PK Parameter: AUClast of GS-829845 |
32466.8; 31412.6 | — |
| PRIMARY PK Parameter: AUCinf of Filgotinib |
2417.0; 1995.9 | — |
| PRIMARY PK Parameter: AUCinf of GS-829845 |
33296.5; 32060.0 | — |
| PRIMARY PK Parameter: Cmax of Filgotinib |
722.6; 802.2 | — |
| PRIMARY PK Parameter: Cmax of GS-829845 |
972.5; 1122.6 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-Emergent Adverse Events |
30.0; 10.0 | — |
| SECONDARY Percentage of Participants Who Experienced Graded Laboratory Abnormalities |
90.0; 70.0; 60.0; 0.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03417778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.