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Completed

NCT Number: NCT04136327

A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection

The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body.

The sponsor will also look at the safety and tolerability of the test medicine.

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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 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
  • A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
  • Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
  • Having a regular daily defecation pattern (i.e. 1 to 3 times per day).

Exclusion criteria

  • Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
  • History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
  • Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first investigational medicinal product (IMP) administration.
  • Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
  • 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 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.

Treatment and study plan

GLPG1972 film-coated tablets

Drug

single oral dose of GLPG1972

[14C]-GLPG1972 solution for infusion

Drug

a 15-minute IV infusion [14C]-GLPG1972

[14C]-GLPG1972 oral solution

Drug

single oral dose of [14C]-GLPG1972

Primary outcomes

  1. Change of total radioactivity excreted in urine and feces combined (Period 2)

    Time frame: From Day 1 pre-dose up to Day 10

    To assess the mass balance, using [14C]-GLPG1972

  2. Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)

    Time frame: From Day 1 pre-dose up to Day 10

    To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma

  3. Cmax of GLPG1972 (Period 2)

    Time frame: From Day 1 pre-dose up to Day 10

    To assess the PK of GLPG1972 and its main metabolites in plasma

  4. Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2)

    Time frame: From Day 1 pre-dose up to Day 10

    To assess the PK of GLPG1972 and its main metabolites in plasma

  5. AUC of GLPG1972 (Period 2)

    Time frame: From Day 1 pre-dose up to Day 10

    To assess the PK of GLPG1972 and its main metabolites in plasma

  6. Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)

    Time frame: From Day 1 pre-dose up to Day 7

    To characterize the elimination pathways and metabolite profile of GLPG1972

Secondary outcomes

  1. Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)

    Time frame: From Day 1 pre-dose up to Day 4

    To assess the PK of GLPG1972 and its main metabolites in plasma

  2. IV Cmax of total radioactivity (Period 1)

    Time frame: From Day 1 pre-dose up to Day 4

    To assess the PK of GLPG1972 and its main metabolites in plasma

  3. IV AUC of [14C]-GLPG1972 MT (Period 1)

    Time frame: From Day 1 pre-dose up to Day 4

    To assess the PK of GLPG1972 and its main metabolites in plasma

  4. IV AUC of total radioactivity (Period 1)

    Time frame: From Day 1 pre-dose up to Day 4

    To assess the PK of GLPG1972 and its main metabolites in plasma

  5. The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations (Period 1 and Period 2)

    Time frame: From Day 1 through study completion, an average of 2 months

    To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1972 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1972 Microtracer and Single Oral [14C]-GLPG1972 Administration

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2019
Registry last updated
Nov 20, 2019

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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