Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C]GLPG3970 solution for infusion; Drug: GLPG3970 film-coated tablet; Drug: [14]GLPG3970 oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04907149

GLPG3970-CL-107

2021-000711-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Absolute Bioavailability - Period 1

Experimental group

Description:

Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.

Treatment:

Drug: [14C]GLPG3970 solution for infusion

Drug: GLPG3970 film-coated tablet

Mass Balance - Period 2

Experimental group

Description:

Participants will receive \[14C\]GLPG397 under fasted conditions on Day 1.

Treatment:

Drug: [14]GLPG3970 oral solution