GLPG0492 Pharmacodynamics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01538420
First received: February 20, 2012
Last updated: April 18, 2012
Last verified: April 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014