Status:
COMPLETED
Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205
Lead Sponsor:
Galapagos NV
Conditions:
Healthy
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief Summary
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the for...
Eligibility Criteria
Inclusion
- Male between 18-64 years of age (extremes included) (Part 1) and between 45-64 years of age (extremes included) (Part 2), on the date of signing the informed consent form.
- A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
- Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).
Exclusion
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, cannot participate in the study.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04704739
Start Date
January 13 2021
End Date
March 10 2021
Last Update
March 25 2021
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS