Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05335447
• Other study ID #: GLPG3667-CL-107
• Secondary ID: 2021-006730-39
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2022
• Est. completion date: June 3, 2022

Study information

• Verified date: June 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3667 capsule
On Day 1, participants will receive a single oral dose of GLPG3667
• [14C]-GLPG3667 solution for infusion
On Day 1, participants will receive a single microtracer microdose of [14C]-GLPG3667 as an intravenous infusion
• [14C]-GLPG3667 capsule
On Day 1, participants will receive a single oral dose of [14C]-GLPG3667

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Limited	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Percentage of TRA in plasma and excreta for metabolites of interest		From Day 1 until at least Day 8 in Period 2
Primary	Absolute oral bioavailability (F[percentage]) of GLPG3667		From Day 1 until Day 4 in Period 1
Secondary	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