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Completed

NCT Number: NCT02612246

First-in-Human Single and Multiple Dose of GLPG1972

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well.

During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males between 18-50 years of age
  • Subjects must have a body mass index between 18-30 kg/m²
  • Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile

Exclusion criteria

  • A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
  • Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device investigational research study
  • A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
  • Current sexually active (and/or child wish) male; a contraception method should be used

Treatment and study plan

GLPG1972 single ascending doses

Drug

single dose, oral solution

Placebo single dose

Drug

single dose, oral solution, matching placebo

GLPG1972 multiple ascending doses

Drug

multiple doses, daily for 14 days, oral solution

Placebo multiple doses

Drug

multiple doses, daily for 14 days, oral solution

Primary outcomes

  1. Change versus placebo in number of subjects with adverse events

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events

  2. Change versus placebo in number of subjects with abnormal laboratory parameters

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters

  3. Change versus placebo in number of subjects with abnormal vital signs

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs

  4. Change versus placebo in number of subjects with abnormal electrocardiogram

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms

  5. Change versus placebo in number of subjects with abnormal physical examination

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination

Secondary outcomes

  1. The amount of GLPG1972 in plasma

    Time frame: Between Day 1 predose and 48 hours after the (last) dose

    To characterize the amount of GLPG1972 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed

  2. The amount of GLPG1972 in urine

    Time frame: Between Day 1 predose and 24 hours after the (last) dose

    To characterize the amount of GLPG1972 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed

  3. Ratio of 6-b-hydroxycortisol/cortisol in urine

    Time frame: Twelve hours before dosing on Day 1 and Day 14

    To assess the potential of CYP3A4 interaction after repeated oral dosing with GLPG1972 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine

  4. Levels of GLPG1972 biomarker in blood

    Time frame: Between Day 1 predose and 48 hours after the last dose

    To assess the pharmacodynamics (PD) of GLPG1972 by means of reduction of levels of biomarker in blood by GLPG1972 compared to placebo after repeated oral dosing

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1972 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 23, 2015
Registry last updated
Jul 29, 2016

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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