Status:
COMPLETED
A Study to Assess Relative Bioavailability of and Effect of Food on a New Oral Tablet Formulation of GLPG3970
Lead Sponsor:
Galapagos NV
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of ...
Eligibility Criteria
Inclusion
- Male or female subject between 18 and 55 years of age (extremes included), on the date of signing the informed consent form .
- A body mass index 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, available at screening and prior to randomization. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be no greater than 1.5x upper limit of normal range. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
- This list only contains the key inclusion criteria.
Exclusion
- Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- This list only contains the key exclusion criterion.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04708184
Start Date
January 11 2021
End Date
February 25 2021
Last Update
March 25 2021
Active Locations (1)
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1
Biotral Rennes
Rennes, France, 35042