First-in-Human Exploratory Single Ascending Dose of GLPG0974
- Registration Number
- NCT01496937
- Lead Sponsor
- Galapagos NV
- Brief Summary
The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.
Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- Healthy male, age 18-50 years
- BMI between 18-30 kg/m2
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLPG0974 oral solution GLPG0974 GLPG0974 oral solution Placebo oral solution GLPG0974 Placebo oral solution
- Primary Outcome Measures
Name Time Method The amount of GLPG0974 in plasma over time after a single oral dose To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects
- Secondary Outcome Measures
Name Time Method Safety and tolerability To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974 To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after a single oral dose in healthy subjects
Trial Locations
- Locations (1)
SGS Stuivenberg
🇧🇪Antwerp, Belgium