Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG1205 film-coated tablets
* Drug: [14C]-GLPG1205 solution for infusion
* Drug: GLPG1205 capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG1205 oral and [14C]-GLPG1205 IV<br>Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion | Drug: GLPG1205 film-coated tablets<br>* Single oral dose of GLPG1205<br>Drug: [14C]-GLPG1205 solution for infusion<br>* A 15-minute IV infusion of [14C]-GLPG1205<br>|
| Experimental: [14C]-GLPG1205 capsule<br>Single oral dose of GLPG1205 as solid formulation | Drug: GLPG1205 capsules<br>* Single oral dose of GLPG1205 as solid formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute oral bioavailability (F) (%) | To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of [14C]-GLPG1205 | Between Day 1 and Day 22 | 
| Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%) | To assess the mass balance recovery after a single oral dose of [14C]-GLPG1205 | Between Day 1 and Day 22 |