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

NCT06043739 | Completed Phase 1

• 1 other identifier: GLPG0634-CL-124
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• AUC0-inf of GS-829845, major active metabolite

  From Day 1 pre-dose until Day 15

Secondary Outcomes (1)

• 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

Study Arms (3)

Treatment A:

ACTIVE COMPARATOR

filgotinib administered under fasting conditions

Drug: Filgotinib

Treatment B:

EXPERIMENTAL

filgotinib administered under fasting conditions

Drug: Filgotinib

Treatment C:

EXPERIMENTAL

filgotinib administered under high-fat fed conditions

Drug: Filgotinib

Interventions

Filgotinib DRUG

Commercially developed film-coated tablet administered orally

Also known as: GS-6034, GLPG0634, Jyseleca

Treatment A:

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Altasciences

Montreal, H3P 3P1, Canada

Location

MeSH Terms

Interventions

GLPG0634

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: September 22, 2023
• Primary Completion: October 27, 2023
• Study Completion: November 12, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)