Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

• Status: Completed
• Trial end date: 2021-03-10
• Target enrollment: 0
• Participant gender: Male

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 form of a capsule or tablet.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galapagos NV

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.