Clinical trial NCT02612246: First-in-Human Single and Multiple Dose of GLPG1972
Official title: Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1972 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 41
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 GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy 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 GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well.

During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.


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

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 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 should 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
Secondary outcomes:
measure: The amount of GLPG1972 in plasma
timeFrame: Between Day 1 predose and 48 hours after the (last) dose
measure: The amount of GLPG1972 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
measure: Levels of GLPG1972 biomarker in blood
timeFrame: Between Day 1 predose and 48 hours after the last dose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Ennis Lee, MD
role: STUDY_DIRECTOR
References: