Skip to main content
OpenTrials
Completed

NCT Number: NCT04704739

Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLPG1205 film-coated tablets

Drug

Single oral dose of GLPG1205

[14C]-GLPG1205 solution for infusion

Drug

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

GLPG1205 capsules

Drug

Single oral dose of GLPG1205 as solid formulation

Primary outcomes

  1. Absolute oral bioavailability (F) (%)

    Time frame: 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

  2. Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%)

    Time frame: Between Day 1 and Day 22

    To assess the mass balance recovery after a single oral dose of [14C]-GLPG1205

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG1205 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1205 Microtracer and Single Oral [14C]-GLPG1205 Administration

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.