Clinical trial NCT02662452: First-in-Human Single and Multiple Dose of GLPG2222
Official title: Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change versus placebo in number of subjects with adverse events
timeFrame: Between screening and 7-10 days after the last dose
measure: Change versus placebo in number of subjects with abnormal laboratory parameters
timeFrame: Between screening and 7-10 days after the last dose
measure: Change versus placebo in number of subjects with abnormal vital signs
timeFrame: Between screening and 7-10 days after the last dose
measure: Change versus placebo in number of subjects with abnormal electrocardiogram
timeFrame: Between screening and 7-10 days after the last dose
measure: Change versus placebo in number of subjects with abnormal physical examination
timeFrame: Between screening and 7-10 days after the last dose
measure: Change versus placebo in number of subjects with abnormal pulmonary function
timeFrame: Between screening and 4 days after the last dose (Part 1 only)
Secondary outcomes:
measure: The amount of GLPG2222 in plasma
timeFrame: Between Day 1 predose and 48 hours after the (last) dose
measure: The amount of GLPG2222 in urine
timeFrame: Between Day 1 predose and 24 hours after the (last) dose
measure: Ratio of 6-b-hydroxycortisol/cortisol in urine
timeFrame: Twelve hours before dosing on Day 1 and Day 14
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Kirsteen Donaldson, MD
role: STUDY_DIRECTOR
References: