GLPG0492 Pharmacodynamics - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: GLPG0492 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:

To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo [ Time Frame: Up to 7 to 10 days after last treatment ] [ Designated as safety issue: Yes ]
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 [ Time Frame: One week ] [ Designated as safety issue: No ]
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 Outcome Measures:

To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492 [ Time Frame: Up to 24h hours after last treatment ] [ Designated as safety issue: No ]
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. [ Time Frame: up to 7 to 10 days after treatment. ] [ Designated as safety issue: No ]
In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed.

Enrollment:	26
Study Start Date:	January 2012
Study Completion Date:	April 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GLPG0492 oral solution Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day	Drug: GLPG0492 Oral solution
Placebo Comparator: Placebo Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2).	Drug: Placebo Placebo oral solution

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538420

Locations

Belgium
SGS Stuivenberg
Antwerp, Belgium

Sponsors and Collaborators

Galapagos NV

Investigators

Study Director:

Florence Namour, MSc

Galapagos SASU

More Information

No publications provided

Responsible Party:	Galapagos NV
ClinicalTrials.gov Identifier:	NCT01538420 History of Changes
Other Study ID Numbers:	GLPG0492-CL-103, 2011-004743-41
Study First Received:	February 20, 2012
Last Updated:	April 18, 2012
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Galapagos NV:

Safety
Tolerability
Pharmacokinetics
Pharmacodynamics

ClinicalTrials.gov processed this record on June 17, 2013