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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004743-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0492 oral solution | Experimental | Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day |
|
| Placebo | Placebo Comparator | Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0492 | Drug | Oral solution |
| |
| Placebo |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Namour, MSc | Galapagos SASU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Belgium |
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| ID | Term |
|---|---|
| C577110 | 4-(4-(hydroxymethyl)-3-methyl-2,5-dioxo-4-phenylimidazolidin-1-yl)-2-(trifluoromethyl)benzonitrile |
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| Drug |
Placebo oral solution |
|
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. |