Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

Sponsor

Galapagos NV (Industry)

Overall Status

Completed

CT.gov ID

NCT05335447

Collaborator

(none)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GLPG3667 capsule Drug: [14C]-GLPG3667 solution for infusion Drug: [14C]-GLPG3667 capsule	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 19, 2022

Actual Primary Completion Date :

Jun 3, 2022

Actual Study Completion Date :

Jun 3, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Limited	Nottingham		United Kingdom	NG11 6JS

Sponsors and Collaborators

Galapagos NV

Investigators

Study Director: Galapagos Study Director, MD, Galapagos NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galapagos NV

ClinicalTrials.gov Identifier:

NCT05335447

Other Study ID Numbers:

GLPG3667-CL-107
2021-006730-39

First Posted:

Apr 19, 2022

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 30, 2022