Evaluation of Mass Balance and Absolute Bioavailability o... | NCT05335447

NCT05335447

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2021-006730-39	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Period 1 - Absolute Bioavailability	Experimental		Drug: GLPG3667 capsule Drug: [14C]-GLPG3667 solution for infusion
Period 2 - Mass Balance	Experimental		Drug: [14C]-GLPG3667 capsule

Name	Type	Description	Arm Group Labels	Other Names
GLPG3667 capsule	Drug	On Day 1, participants will receive a single oral dose of GLPG3667	Period 1 - Absolute Bioavailability

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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 Module

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.