A Phase I, open-label, drug-drug interaction study between multiple oral doses of GLPG1972 and a single dose of midazolam in healthy male subjects.
Completed
- Conditions
- Osteoarthritis.10023213
- Registration Number
- NL-OMON44611
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
healthy male volunteers
18 - 50 years, inclusive
BMI 18.0 - 30.0 kg/m2
weight at least 50 kilograms
non smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study. Not allowed is the use of any prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g. St. John*s Wort), from 14 days prior to the first administration of the study compound until the post-study visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the effect of multiple oral doses of GLPG1972 (300 mg q.d.) on the<br /><br>single oral dose PK of midazolam (2 mg) in healthy male subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of multiple oral doses of GLPG1972<br /><br>administered with a single oral dose of midazolam or without midazolam in<br /><br>healthy male subjects.</p><br>