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

Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06043739
• Other study ID #: GLPG0634-CL-124
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2023
• Est. completion date: November 12, 2023

Study information

• Verified date: November 2023
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 12, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• Filgotinib
Commercially developed film-coated tablet administered orally
• Filgotinib
Film-coated mini-tablets administered orally

Locations

Country	Name	City	State
Canada	Altasciences	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Canada, 

Outcome

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