Clinical trial NCT02179502: First-in-Human Single and Multiple Dose of GLPG1690
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2014-07-01
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Between screening and 7-10 days after the last dose
measure: Number of subjects with abnormal laboratory parameters
timeFrame: Between screening and 7-10 days after the last dose
measure: Number of subjects with abnormal vital signs
timeFrame: Between screening and 7-10 days after the last dose
measure: Number of subjects with abnormal electrocardiogram
timeFrame: Between screening and 7-10 days after the last dose
measure: Number of subjects with abnormal physical examination
timeFrame: Between screening and 7-10 days after the last dose
Secondary outcomes:
measure: The amount of GLPG1690 in plasma
timeFrame: Between Day 1 predose and 48 hours after the (last) dose
measure: The amount of GLPG1690 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 biomarker in plasma
timeFrame: Day 1 predose up to 48 hours post (last) dose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References:
citation: van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.