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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: Filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06043739

GLPG0634-CL-124

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Treatment A:

Active Comparator group

Description:

filgotinib administered under fasting conditions

Treatment:

Drug: Filgotinib

Drug: Filgotinib

Treatment B:

Experimental group

Description:

filgotinib administered under fasting conditions

Treatment:

Drug: Filgotinib

Drug: Filgotinib

Treatment C:

Experimental group

Description:

filgotinib administered under high-fat fed conditions

Treatment:

Drug: Filgotinib

Drug: Filgotinib