Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

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 GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 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 GLPG0492 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0492
* 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 18-29.9 kg/m², inclusive. normal values of testosterone (2.49-8.36 ng/mL) and LH (1.7-8.6 U/L) Exclusion Criteria: smoking drug or alcohol abuse hypersensitivity to any of the ingredients of the study drug

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: GLPG0492 oral solution<br>Multiple ascending doses once daily for 14 days, starting from 5 mg/day | Drug: GLPG0492<br>* Oral solution<br>|
| Placebo Comparator: Placebo oral solution<br>Once daily dosing for 14 days | Drug: Placebo<br>* Oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo | Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability | Up to 2 weeks after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492 | The plasma levels of GLPG0492 will be determined as a measure of pharmacokinetics, and the plasma and urine levels of GLPG0492 will be used for metabolism investigation | Up to 2h hours after last treatment | 
| To assess whether GLPG0492 induces CYP450, a pharmacodynamic marker by measuring the ratio of β-OH-cortisol /cortisol in urine | To assess the potential of daily doses of GLPG0492 to induce cytochrome P450(CYP3A4), a pharmacodynamic marker, by measurement of the ratio of β-OH-cortisol /cortisol in urine | Up to 24 hours after last treatment | 

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