Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

An Open-label Study in Healthy Male Subjects to Investigate the Metabolism and Excretion Pathways of GLPG3667 Following a Single Oral Dose of [14C]-GLPG3667 and to Determine the Absolute Bioavailability Relative to an Intravenous [14C]-GLPG3667 Microtracer

This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG3667 capsule; Drug: [14C]-GLPG3667 solution for infusion; Drug: [14C]-GLPG3667 capsule

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.
• Has a regular daily defecation pattern (i.e. 1 to 3 times per day).
• Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal range. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

• Known hypersensitivity to GLPG3667 ingredients or history of a significant allergic reaction to GLPG3667 ingredients as determined by the investigator
• Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, COVID-19 vaccines, dietary supplements, nutraceuticals, vitamins and/or herbal supplements), except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
• Subject 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 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 (UK, 2017), cannot participate in the study.

This list only contains the key exclusion criteria.

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: Period 1 - Absolute Bioavailability	Drug: GLPG3667 capsule; On Day 1, participants will receive a single oral dose of GLPG3667; Drug: [14C]-GLPG3667 solution for infusion; On Day 1, participants will receive a single microtracer microdose of [14C]-GLPG3667 as an intravenous infusion
Experimental: Period 2 - Mass Balance	Drug: [14C]-GLPG3667 capsule; On Day 1, participants will receive a single oral dose of [14C]-GLPG3667

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%)	From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)	From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)	From Day 1 until at least Day 8 in Period 2
Percentage of TRA in plasma and excreta for metabolites of interest	From Day 1 until at least Day 8 in Period 2
Absolute oral bioavailability (F[percentage]) of GLPG3667	From Day 1 until Day 4 in Period 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.	From Day 1 through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Galapagos Study Director, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GLPG3667-CL-107; 2021-006730-39 (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