A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG1205 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1205 Microtracer and Single Oral [14C]-GLPG1205 Administration
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Absolute oral bioavailability (F) (%)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
GLPG1205 oral and [14C]-GLPG1205 IV
Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion
Intervention: GLPG1205 film-coated tablets (Drug)
GLPG1205 oral and [14C]-GLPG1205 IV
Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion
Intervention: [14C]-GLPG1205 solution for infusion (Drug)
[14C]-GLPG1205 capsule
Single oral dose of GLPG1205 as solid formulation
Intervention: GLPG1205 capsules (Drug)
Outcomes
Primary Outcomes
Absolute oral bioavailability (F) (%)
Time Frame: 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%)
Time Frame: Between Day 1 and Day 22
To assess the mass balance recovery after a single oral dose of \[14C\]-GLPG1205
Secondary Outcomes
No secondary outcomes reported