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OpenTrials
Completed

NCT Number: NCT05335447

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.

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Key information

Conditions

Age range

30 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Limited

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.
  • 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.

Treatment and study plan

GLPG3667 capsule

Drug

On Day 1, participants will receive a single oral dose of GLPG3667

[14C]-GLPG3667 solution for infusion

Drug

On Day 1, participants will receive a single microtracer microdose of [14C]-GLPG3667 as an intravenous infusion

[14C]-GLPG3667 capsule

Drug

On Day 1, participants will receive a single oral dose of [14C]-GLPG3667

Primary outcomes

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

    Time frame: From Day 1 until at least Day 8 in Period 2

  2. Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)

    Time frame: From Day 1 until at least Day 8 in Period 2

  3. Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)

    Time frame: From Day 1 until at least Day 8 in Period 2

  4. Percentage of TRA in plasma and excreta for metabolites of interest

    Time frame: From Day 1 until at least Day 8 in Period 2

  5. Absolute oral bioavailability (F[percentage]) of GLPG3667

    Time frame: From Day 1 until Day 4 in Period 1

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 2 months

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

An Open-label Study in Healthy Male Subjects to Investigate the Metabolism and Excretion Pathways of GLPG3667 Following a Single Oral Dose of [14C]-GLPG3667 and to Determine the Absolute Bioavailability Relative to an Intravenous [14C]-GLPG3667 Microtracer

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Jun 30, 2022

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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