A Phase 1 interventional study of GLPG0492 and Placebo in Healthy, sponsored by Galapagos NV. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-19.
Sponsored by Galapagos NV · Phase 1, Interventional, and Treatment
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.
Galapagos NV is the lead sponsor of 103 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day
Drug: GLPG0492
Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2).
Drug: Placebo
Oral solution
Placebo oral solution
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
Time frame: 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.
Time frame: One week
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
Time frame: 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.
Time frame: up to 7 to 10 days after treatment.
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Galapagos NV