Clinical trial

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

ID

Name

GLPG0634-CL-124

Description

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.

Trial arms

Trial start

2023-09-22

Estimated PCD

2023-10-27

Trial end

2023-11-12

Status

Completed

Phase

Early phase I

Treatment

Filgotinib

Commercially developed film-coated tablet administered orally

Arms:

Treatment A:

Other names:

GS-6034, GLPG0634, Jyseleca

Filgotinib

Film-coated mini-tablets administered orally

Arms:

Treatment B:, Treatment C:

Other names:

GS-6034, GLPG0634

Size

12

Primary endpoint

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

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2023-11-29

1 organization

1 product

1 indication

Product

Indication

Bioavailability

Organization