Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2014-06-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
First-in-Human Single and Multiple Dose of GLPG1972
NCT02612246
First-in-Human Single and Multiple Dose of GLPG1205
NCT01887106
First-in-Human Single Ascending and Multiple Dose of GLPG0259
NCT00905138
First-in-Human Single Ascending and Multiple Dose of GLPG0634
NCT01179581
Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects
NCT01721980
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GLPG1690 single dose
Single oral dose of GLPG1690 suspension or solid formulation - ascending doses
GLPG1690 single ascending doses
Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
Placebo single dose
Single oral dose of placebo suspension or solid formulation
Placebo single ascending doses
Single dose, oral suspension or solid formulation matching placebo
GLPG1690 multiple doses
Multiple oral doses of GLPG1690 suspension - ascending doses
GLPG1690, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
Placebo multiple doses
Multiple oral doses of placebo suspension
Placebo, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension matching placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GLPG1690 single ascending doses
Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
Placebo single ascending doses
Single dose, oral suspension or solid formulation matching placebo
GLPG1690, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
Placebo, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension matching placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI between 18-30 kg/m2
Exclusion Criteria
* Drug or alcohol abuse
* Smoking
18 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galapagos NV
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frédéric Vanhoutte, MD
Role: STUDY_DIRECTOR
Galapagos NV
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Antwerp, Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-000981-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG1690-CL-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.