Healthy
Conditions
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 form of a capsule or tablet.
Interventions
DRUGGLPG1205 film-coated tablets
Single oral dose of GLPG1205
DRUG[14C]-GLPG1205 solution for infusion
A 15-minute IV infusion of \[14C\]-GLPG1205
DRUGGLPG1205 capsules
Single oral dose of GLPG1205 as solid formulation
Sponsors
Galapagos NV
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute oral bioavailability (F) (%) | Between Day 1 and Day 22 | To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of \[14C\]-GLPG1205 |
| Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%) | Between Day 1 and Day 22 | To assess the mass balance recovery after a single oral dose of \[14C\]-GLPG1205 |
Countries
United Kingdom
Outcome results
None listed