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First-in-Human Single and Multiple Dose of GLPG2222

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ClinicalTrials.gov Identifier: NCT02662452
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG2222 single dose Drug: Placebo single dose Drug: GLPG2222 multiple doses Drug: Placebo multiple doses Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects
Study Start Date : January 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: GLPG2222 single dose
Single dose of GLPG2222 oral suspension
Drug: GLPG2222 single dose
single ascending doses, oral suspension

Placebo Comparator: Placebo single dose
Single dose of placebo oral suspension
Drug: Placebo single dose
single doses, oral suspension, matching placebo

Experimental: GLPG2222 multiple doses
Multiple doses of GLPG2222 oral suspension
Drug: GLPG2222 multiple doses
multiple ascending doses, daily for 14 days, oral suspension

Placebo Comparator: Placebo multiple doses
Multiple doses of placebo oral suspension
Drug: Placebo multiple doses
multiple doses, daily for 14 days, oral suspension, matching placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662452


Locations
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Belgium
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Kirsteen Donaldson, MD Galapagos NV
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT02662452    
Other Study ID Numbers: GLPG2222-CL-101
2015-004466-29 ( EudraCT Number )
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No