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Completed

NCT Number: NCT02179502

First-in-Human Single and Multiple Dose of GLPG1690

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.

The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.

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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

  • Healthy male, age 18-50 years
  • BMI between 18-30 kg/m2

Exclusion criteria

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Treatment and study plan

GLPG1690 single ascending doses

Drug

Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg

Placebo single ascending doses

Drug

Single dose, oral suspension or solid formulation matching placebo

GLPG1690, multiple ascending doses, oral suspension

Drug

Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg

Placebo, multiple ascending doses, oral suspension

Drug

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

Primary outcomes

  1. 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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events

  2. 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 GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters

  3. 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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs

  4. 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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram

  5. 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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination

Secondary outcomes

  1. The amount of GLPG1690 in plasma

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

    To characterize the amount of GLPG1690 in plasma over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation

  2. The amount of GLPG1690 in urine

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

    To characterize the amount of GLPG1690 in urine over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation

  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 induction after repeated dosing with GLPG1690 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine

  4. Levels of biomarker in plasma

    Time frame: Day 1 predose up to 48 hours post (last) dose

    To characterize the pharmacodynamics (PD) of GLPG1690 by means of reduction of levels of biomarker by GLPG1690 compared to placebo in plasma after single and multiple oral dose in healthy subjects

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 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1690 in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 1, 2014
Registry last updated
Sep 22, 2015

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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