Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Galapagos NV12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

GLPG1205 film-coated tabletsDRUG

Single oral dose of GLPG1205

[14C]-GLPG1205 solution for infusionDRUG

A 15-minute IV infusion of \[14C\]-GLPG1205

GLPG1205 capsulesDRUG

Single oral dose of GLPG1205 as solid formulation

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quotient Sciences

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Between Day 1 and Day 22

Data from ClinicalTrials.gov

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