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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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.|
- To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo [ Time Frame: Up to 7 to 10 days after last treatment ] [ Designated as safety issue: Yes ]Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability
- In male volunteers: effect on protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine [ Time Frame: One week ] [ Designated as safety issue: No ]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.
- To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492 [ Time Frame: Up to 24h hours after last treatment ] [ Designated as safety issue: No ]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
- In female volunteers: effects on hormone household. [ Time Frame: up to 7 to 10 days after treatment. ] [ Designated as safety issue: No ]In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed.
|Study Start Date:||January 2012|
|Study Completion Date:||April 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: GLPG0492 oral solution
Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day
Placebo Comparator: Placebo
Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2).
Placebo oral solution
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538420
|Study Director:||Florence Namour, MSc||Galapagos SASU|