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

Sponsor
Galapagos NV (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06043739
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
2
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment A:

filgotinib administered under fasting conditions

Drug: Filgotinib
Commercially developed film-coated tablet administered orally
Other Names:
  • GS-6034
  • GLPG0634
  • Jyseleca

    		•
    Experimental: Treatment B:

    filgotinib administered under fasting conditions

    Drug: Filgotinib
    Film-coated mini-tablets administered orally
    Other Names:
  • GS-6034
  • GLPG0634

    		•
    Experimental: Treatment C:

    filgotinib administered under high-fat fed conditions

    Drug: Filgotinib
    Film-coated mini-tablets administered orally
    Other Names:
  • GS-6034
  • GLPG0634

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration of filgotinib (Cmax) [From Day 1 pre-dose until Day 15]

    2. Cmax of GS-829845, major active metabolite [From Day 1 pre-dose until Day 15]

    3. 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]

    4. AUC0-t of GS-829845, major active metabolite [From Day 1 pre-dose until Day 15]

    5. Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf) [From Day 1 pre-dose until Day 15]

    6. AUC0-inf of GS-829845, major active metabolite [From Day 1 pre-dose until Day 15]

    Secondary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altasciences Montréal Canada H3P 3P1

    Sponsors and Collaborators

    • Galapagos NV

    Investigators

    • Study Director: Galapagos Study Director, Galapagos NV

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galapagos NV
    ClinicalTrials.gov Identifier:
    NCT06043739
    Other Study ID Numbers:
    • GLPG0634-CL-124
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 21, 2023