GLPG0492 Pharmacodynamics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG0492 oral solution

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

Group Type EXPERIMENTAL

GLPG0492

Intervention Type DRUG

Oral solution

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral solution

Interventions

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GLPG0492

Oral solution

Intervention Type DRUG

Placebo

Placebo oral solution

Intervention Type DRUG

Eligibility Criteria

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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).