Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2021-03-10

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GLPG1205 oral and [14C]-GLPG1205 IV

Single oral dose of GLPG1205 followed by \[14C\]-GLPG1205 solution for infusion

Group Type EXPERIMENTAL

GLPG1205 film-coated tablets

Intervention Type DRUG

Single oral dose of GLPG1205

[14C]-GLPG1205 solution for infusion

Intervention Type DRUG

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

[14C]-GLPG1205 capsule

Single oral dose of GLPG1205 as solid formulation

Group Type EXPERIMENTAL

GLPG1205 capsules

Intervention Type DRUG

Single oral dose of GLPG1205 as solid formulation

Interventions

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GLPG1205 film-coated tablets

Single oral dose of GLPG1205

Intervention Type DRUG

[14C]-GLPG1205 solution for infusion

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

Intervention Type DRUG

GLPG1205 capsules

Single oral dose of GLPG1205 as solid formulation

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes