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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01538420

Enrollment

Registered

2012-02-24

Start date

2012-01-31

Completion date

2012-04-30

Last updated

2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics

Brief 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.

Interventions

DRUGGLPG0492

Oral solution

DRUGPlacebo

Placebo oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo	Up to 7 to 10 days after last treatment	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	One week	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.

Secondary

Measure	Time frame	Description
To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492	Up to 24h hours after last treatment	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.	up to 7 to 10 days after treatment.	In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026