Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects

A Randomized, Open-label, 3-period, Single-dose, Cross-over Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Filgotinib Given as an Oral Mini-tablet Formulation Versus the Oral Tablet Formulation of Filgotinib and to Assess the Effect of Food on the Oral Mini-tablet Formulation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06043739

Enrollment

Registered

2023-09-21

Start date

2023-09-22

Completion date

2023-11-12

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability

Brief summary

Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus oral tablet formulation and effect of food on the mini-tablet formulation.

Interventions

DRUGFilgotinib

Commercially developed film-coated tablet administered orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN) and total bilirubin not greater than ULN. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator. Key

Exclusion criteria

* Known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator. * Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration of filgotinib (AUC0-t)	From Day 1 pre-dose until Day 15
Maximum observed plasma concentration of filgotinib (Cmax)	From Day 1 pre-dose until Day 15
Cmax of GS-829845, major active metabolite	From Day 1 pre-dose until Day 15
AUC0-inf of GS-829845, major active metabolite	From Day 1 pre-dose until Day 15
AUC0-t of GS-829845, major active metabolite	From Day 1 pre-dose until Day 15
Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf)	From Day 1 pre-dose until Day 15

Secondary

Measure	Time frame
Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations	Baseline (Day 1) up to 30 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026