GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0778
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male, age 18-50 years body mass index (BMI) between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse hypersensitivity to any of the test substances

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0778 ascending doses<br>Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation. | Drug: GLPG0778<br>* capsules containing 50 or 100 mg of GLPG0778<br>|
| Placebo Comparator: Placebo<br>Twice daily for 13 days, matching the scheme of the multiple ascending dose. | Drug: placebo<br>* multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment. | Daily during treatment, up to 10 days postdose | 
| Evaluation of hematological, biochemical and cardiovascular parameters. | 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. | until 10 days postdose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of repeated doses | 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). | 24 hours postdose | 
| Pharmacodynamics (PD) of GLPG0778 | To explore biomarkers of GLPG0778 activity after repeated oral administrations. | up to 10 days postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability, Pharmacokinetics