Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

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 tablet and an oral solution.

Official Title
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A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG3970 film-coated tablet
* Drug: [14C]GLPG3970 solution for infusion
* Drug: [14]GLPG3970 oral solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF). A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive. Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day). This list only contains the key inclusion criteria. Exclusion Criteria: Participant has participated in a [14C]radiolabeled study within the past 12 months. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 month or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study. This list only contains the key exclusion criteria.

Ages Eligible for Study
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Minimum Age: 30 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: Absolute Bioavailability - Period 1<br>Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1. | Drug: GLPG3970 film-coated tablet<br>* Participants will receive a single oral dose of GLPG3970.<br>Drug: [14C]GLPG3970 solution for infusion<br>* Participants will receive an i.v. microtracer microdose.<br>|
| Experimental: Mass Balance - Period 2<br>Participants will receive [14C]GLPG397 under fasted conditions on Day 1. | Drug: [14]GLPG3970 oral solution<br>* Participants will receive a single oral dose [14C]GLPG3970.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute oral bioavailability (F [%]) of GLPG3970 |  | From Day 1 pre-dose until Day 4 in Period 1 | 
| Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%). |  | From Day 1 pre-dose until Day 8 in Period 2 | 
| Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%). |  | From Day 1 pre-dose until Day 8 in Period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations. |  | From Day 1 through study completion, an average of 1 month |