Status:
COMPLETED
Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
Lead Sponsor:
Galapagos NV
Conditions:
Bioavailability
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06043739
Start Date
September 22 2023
End Date
November 12 2023
Last Update
November 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altasciences
Montreal, Canada, H3P 3P1