GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects|
- Occurrence of adverse events [ Time Frame: Daily during treatment, up to 10 days postdose ] [ Designated as safety issue: No ]At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
- Evaluation of hematological, biochemical and cardiovascular parameters. [ Time Frame: until 10 days postdose. ] [ Designated as safety issue: No ]On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
- Pharmacokinetics of repeated doses [ Time Frame: 24 hours postdose ] [ Designated as safety issue: No ]Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).
- Pharmacodynamics (PD) of GLPG0778 [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]To explore biomarkers of GLPG0778 activity after repeated oral administrations.
|Study Start Date:||April 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: GLPG0778 ascending doses
Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.
capsules containing 50 or 100 mg of GLPG0778
Placebo Comparator: Placebo
Twice daily for 13 days, matching the scheme of the multiple ascending dose.
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336244
|Study Director:||Gerben van 't Klooster, PhD||Galapagos NV|
|Principal Investigator:||Lien Gheyle, MD||SGS Stuivenberg|