Clinical trial NCT05335447: Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 5
Sex: MALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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.

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.

Primary outcomes:
measure: Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%)
timeFrame: From Day 1 until at least Day 8 in Period 2
measure: Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)
timeFrame: From Day 1 until at least Day 8 in Period 2
measure: Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)
timeFrame: From Day 1 until at least Day 8 in Period 2
measure: Percentage of TRA in plasma and excreta for metabolites of interest
timeFrame: From Day 1 until at least Day 8 in Period 2
measure: Absolute oral bioavailability (F[percentage]) of GLPG3667
timeFrame: From Day 1 until Day 4 in Period 1
Secondary outcomes:
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
timeFrame: From Day 1 through study completion, an average of 2 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Limited
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director, MD
role: STUDY_DIRECTOR
References: