Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG1205 film-coated tablets; Drug: GLPG1205 capsules; Drug: [14C]-GLPG1205 solution for infusion

• Registration Number: NCT04704739
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Study Start: 2021-01-13
• Status Verified: 2021-03
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-10
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GLPG1205 oral and [14C]-GLPG1205 IV	GLPG1205 film-coated tablets	Single oral dose of GLPG1205 followed by \[14C\]-GLPG1205 solution for infusion
GLPG1205 oral and [14C]-GLPG1205 IV	[14C]-GLPG1205 solution for infusion	Single oral dose of GLPG1205 followed by \[14C\]-GLPG1205 solution for infusion
[14C]-GLPG1205 capsule	GLPG1205 capsules	Single oral dose of GLPG1205 as solid formulation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom