Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2021-07-12

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.

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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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Absolute Bioavailability - Period 1

Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.

Group Type EXPERIMENTAL

GLPG3970 film-coated tablet

Intervention Type DRUG

Participants will receive a single oral dose of GLPG3970.

[14C]GLPG3970 solution for infusion

Intervention Type DRUG

Participants will receive an i.v. microtracer microdose.

Mass Balance - Period 2

Participants will receive \[14C\]GLPG397 under fasted conditions on Day 1.

Group Type EXPERIMENTAL

[14]GLPG3970 oral solution

Intervention Type DRUG

Participants will receive a single oral dose \[14C\]GLPG3970.

Interventions

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GLPG3970 film-coated tablet

Participants will receive a single oral dose of GLPG3970.

Intervention Type DRUG

[14C]GLPG3970 solution for infusion

Participants will receive an i.v. microtracer microdose.

Intervention Type DRUG

[14]GLPG3970 oral solution

Participants will receive a single oral dose \[14C\]GLPG3970.

Intervention Type DRUG

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).

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes