Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
NCT ID: NCT06043739
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2023-09-22
2023-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A:
filgotinib administered under fasting conditions
Filgotinib
Commercially developed film-coated tablet administered orally
Treatment B:
filgotinib administered under fasting conditions
Filgotinib
Film-coated mini-tablets administered orally
Treatment C:
filgotinib administered under high-fat fed conditions
Filgotinib
Film-coated mini-tablets administered orally
Interventions
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Filgotinib
Commercially developed film-coated tablet administered orally
Filgotinib
Film-coated mini-tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Altasciences
Montreal, , Canada
Countries
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Other Identifiers
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GLPG0634-CL-124
Identifier Type: -
Identifier Source: org_study_id