Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

NCT05335447 | Completed Phase 1

• 2 other identifiers: GLPG3667-CL-1072021-006730-39
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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

Study Arms (2)

Period 1 - Absolute Bioavailability

EXPERIMENTAL

Drug: GLPG3667 capsule; Drug: [14C]-GLPG3667 solution for infusion

Period 2 - Mass Balance

EXPERIMENTAL

Drug: [14C]-GLPG3667 capsule

Interventions

GLPG3667 capsule DRUG

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

Period 1 - Absolute Bioavailability

[14C]-GLPG3667 solution for infusion DRUG

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

Period 1 - Absolute Bioavailability

[14C]-GLPG3667 capsule DRUG

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

Period 2 - Mass Balance

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Quotient Sciences Limited

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Galapagos Study Director, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: April 19, 2022
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)