GLPG0492 Pharmacodynamics

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: GLPG0492

Study type: Interventional

Funder types: Industry

Identifiers

NCT01538420

GLPG0492-CL-103

2011-004743-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

GLPG0492 oral solution

Experimental group

Description:

Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day

Treatment:

Drug: GLPG0492

Placebo

Placebo Comparator group

Description:

Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2).

Treatment:

Drug: Placebo