GLPG0492 Pharmacodynamics

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538420
• Other study ID #: GLPG0492-CL-103
• Secondary ID: 2011-004743-41
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2012
• Last updated: April 18, 2012
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0492
Oral solution
• Placebo
Placebo oral solution

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo	Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability	Up to 7 to 10 days after last treatment	Yes
Primary	In male volunteers: effect on protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine	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.	One week	No
Secondary	To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492	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	Up to 24h hours after last treatment	No
Secondary	In female volunteers: effects on hormone household.	In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed.	up to 7 to 10 days after treatment.	No