Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04907149

Enrollment

Registered

2021-05-28

Start date

2021-06-07

Completion date

2021-07-12

Last updated

2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGGLPG3970 film-coated tablet

Participants will receive a single oral dose of GLPG3970.

DRUG[14C]GLPG3970 solution for infusion

Participants will receive an i.v. microtracer microdose.

DRUG[14]GLPG3970 oral solution

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Absolute oral bioavailability (F [%]) of GLPG3970	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%).	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%).	From Day 1 pre-dose until Day 8 in Period 2

Secondary

Measure	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 1 month

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026