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OpenTrials
Completed

NCT Number: NCT04907149

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

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.

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Key information

Conditions

Healthy

Age range

30 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Ltd

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLPG3970 film-coated tablet

Drug

Participants will receive a single oral dose of GLPG3970.

[14C]GLPG3970 solution for infusion

Drug

Participants will receive an i.v. microtracer microdose.

[14]GLPG3970 oral solution

Drug

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

Primary outcomes

  1. Absolute oral bioavailability (F [%]) of GLPG3970

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

  2. 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

  3. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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