NCT01538420

GLPG0492 Pharmacodynamics

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0492	Oral solution
DRUG	Placebo	Placebo oral solution

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2012-02-24
• Last updated: 2012-04-19

Locations

1 site across 1 country: Belgium