Skip to main content
OpenTrials
Completed

NCT Number: NCT02662452

First-in-Human Single and Multiple Dose of GLPG2222

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.

The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Completed

Looking for future studies?

Notify Me

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
  • Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)

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 or biologic 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 must be used

Treatment and study plan

GLPG2222 single dose

Drug

single ascending doses, oral suspension

Placebo single dose

Drug

single doses, oral suspension, matching placebo

GLPG2222 multiple doses

Drug

multiple ascending doses, daily for 14 days, oral suspension

Placebo multiple doses

Drug

multiple doses, daily for 14 days, oral suspension, matching placebo

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 GLPG2222 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 GLPG2222 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 GLPG2222 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram

  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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination

  6. Change versus placebo in number of subjects with abnormal pulmonary function

    Time frame: Between screening and 4 days after the last dose (Part 1 only)

    To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry

Secondary outcomes

  1. The amount of GLPG2222 in plasma

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

    To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects

  2. The amount of GLPG2222 in urine

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

    To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects

  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 GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2016
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.