Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

NCT ID: NCT05335447

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2022-06-03

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Period 1 - Absolute Bioavailability

Group Type: EXPERIMENTAL

GLPG3667 capsule

Intervention Type: DRUG

On Day 1, participants will receive a single oral dose of GLPG3667

[14C]-GLPG3667 solution for infusion

Intervention Type: DRUG

On Day 1, participants will receive a single microtracer microdose of \[14C\]-GLPG3667 as an intravenous infusion

Period 2 - Mass Balance

Group Type: EXPERIMENTAL

[14C]-GLPG3667 capsule

Intervention Type: DRUG

On Day 1, participants will receive a single oral dose of \[14C\]-GLPG3667

Interventions

GLPG3667 capsule

On Day 1, participants will receive a single oral dose of GLPG3667

Intervention Type: DRUG

[14C]-GLPG3667 solution for infusion

On Day 1, participants will receive a single microtracer microdose of \[14C\]-GLPG3667 as an intravenous infusion

Intervention Type: DRUG

[14C]-GLPG3667 capsule

On Day 1, participants will receive a single oral dose of \[14C\]-GLPG3667

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Galapagos Study Director, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Quotient Sciences Limited

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2021-006730-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3667-CL-107

Identifier Type: -

Identifier Source: org_study_id