First-in-Human Single and Multiple Dose of GLPG1690

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2014

Interventions

  • Drug: GLPG1690 single ascending doses
    • Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
  • Drug: Placebo single ascending doses
    • Single dose, oral suspension or solid formulation matching placebo
  • Drug: GLPG1690, multiple ascending doses, oral suspension
    • Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
  • Drug: Placebo, multiple ascending doses, oral suspension
    • Multiple doses, daily for 14 days, oral suspension matching placebo

Arms, Groups and Cohorts

  • Experimental: GLPG1690 single dose
    • Single oral dose of GLPG1690 suspension or solid formulation – ascending doses
  • Placebo Comparator: Placebo single dose
    • Single oral dose of placebo suspension or solid formulation
  • Experimental: GLPG1690 multiple doses
    • Multiple oral doses of GLPG1690 suspension – ascending doses
  • Placebo Comparator: Placebo multiple doses
    • Multiple oral doses of placebo suspension

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Galapagos NV
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Frédéric Vanhoutte, MD, Study Director, Galapagos NV

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