Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

Lakefront Biotherapeutics NV6 enrolled

Overview

A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

GLPG3970 film-coated tabletDRUG

Participants will receive a single oral dose of GLPG3970.

[14C]GLPG3970 solution for infusionDRUG

Participants will receive an i.v. microtracer microdose.

[14]GLPG3970 oral solutionDRUG

Participants will receive a single oral dose \[14C\]GLPG3970.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. * Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day). This list only contains the key inclusion criteria. Exclusion Criteria: * Participant 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 mSv in the last 12 month 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.

Locations (1)

Quotient Sciences Ltd

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Absolute oral bioavailability (F [%]) of GLPG3970

Time frame: From Day 1 pre-dose until Day 4 in Period 1

Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).

Time frame: From Day 1 pre-dose until Day 8 in Period 2

Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).

Time frame: From Day 1 pre-dose until Day 8 in Period 2

Secondary Outcomes

Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.

Time frame: From Day 1 through study completion, an average of 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.