Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG1205 film-coated tablets; Drug: [14C]-GLPG1205 solution for infusion; Drug: GLPG1205 capsules

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG1205 oral and [14C]-GLPG1205 IV; Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion	Drug: GLPG1205 film-coated tablets; Single oral dose of GLPG1205; Drug: [14C]-GLPG1205 solution for infusion; A 15-minute IV infusion of [14C]-GLPG1205
Experimental: [14C]-GLPG1205 capsule; Single oral dose of GLPG1205 as solid formulation	Drug: GLPG1205 capsules; Single oral dose of GLPG1205 as solid formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Between Day 1 and Day 22

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GLPG1205-CL-109; 2020-004550-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No