GLPG0492 Pharmacodynamics

Study Overview
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Brief Summary
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GLPG0492 is a selective androgen receptor modulator: the compound should help protect against (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone). In the first part of the current study it will be tested whether GLPG0492 given orally to healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine. In the second part of the study, the effect of the compound on the hormone household in healthy, postmenopausal women will be assessed.

Official Title
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Assessment of the Muscle Protein Fractional Synthesis Rate Induced by Repeated Administrations of GLPG0492 to Healthy Male Subjects and Assessment of the Safety, Tolerability and Pharmacokinetics of Repeated Administrations of GLPG0492 to Healthy Postmenopausal Women.

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 (for part 1), and postmenopausal subjects age 35-65 years (for part 2) Body mass index (BMI) between 18-30 kg/m², inclusive. For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L). Women must be postmenopausal for at least 2 years with postmenopausal FSH level according to the local lab (+negative pregnancy test at screening & admission). 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: 65 Years

Sexes Eligible for Study
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All

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

Primary Purpose: Treatment
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 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day | Drug: GLPG0492<br>* Oral solution<br>|
| Placebo Comparator: Placebo<br>Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2). | Drug: Placebo<br>* Placebo 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 7 to 10 days after last treatment | 
| In male volunteers: effect on protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine | During a 5-hour infusion of phenylalanine two muscle biopsies will be taken; this procedure is performed before and after one week of treatment with GLPG0492, to determine the effect of the compound. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492 | The plasma levels of GLPG0492 will be determined as a measure of pharmacokinetics, and the plasma and urine samples will be used for metabolism investigation | Up to 24h hours after last treatment | 
| In female volunteers: effects on hormone household. | In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed. | up to 7 to 10 days after treatment. | 

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