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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Change versus placebo in number of subjects with abnormal electrocardiogram
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
GLPG1972 single dose
Single oral dose of GLPG1972 solution - ascending doses
Intervention: GLPG1972 single ascending doses (Drug)
Placebo single dose
Single oral dose of placebo solution
Intervention: Placebo single dose (Drug)
GLPG1972 multiple doses
Multiple oral doses of GLPG1972 solution - ascending doses
Intervention: GLPG1972 multiple ascending doses (Drug)
Placebo multiple doses
Multiple oral doses of placebo solution
Intervention: Placebo multiple doses (Drug)
Outcomes
Primary Outcomes
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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Secondary Outcomes
- Levels of GLPG1972 biomarker in blood(Between Day 1 predose and 48 hours after the last dose)
- The amount of GLPG1972 in urine(Between Day 1 predose and 24 hours after the (last) dose)
- Ratio of 6-b-hydroxycortisol/cortisol in urine(Twelve hours before dosing on Day 1 and Day 14)
- The amount of GLPG1972 in plasma(Between Day 1 predose and 48 hours after the (last) dose)