Biomarkers of Muscle Anabolism - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00812396

Purpose

This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.

Condition	Intervention	Phase
Muscle Anabolism	Drug: Comparator: low dose testosterone Drug: Comparator: high dose testosterone Drug: Comparator: placebo	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism

Resource links provided by NLM:

Further study details as provided by Merck:

Primary Outcome Measures:

comparative proteomics on proteins present in the vastus lateralis or plasma [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mRNA or miRNA expression in the vastus lateralis or in peripheral blood [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	November 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Low dose testosterone	Drug: Comparator: low dose testosterone Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
2: Active Comparator High dose testosterone	Drug: Comparator: high dose testosterone Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.
3: Placebo Comparator Placebo	Drug: Comparator: placebo Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

subject is a regular user of illicit drugs
subject has taken androgenic steroids in the past 12 months
subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
subject has prostate cancer
subject has HIV and/or hepatitis B or C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812396

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_602, 082
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812396 History of Changes
Health Authority:	Ireland: Irish Medicines Board

Keywords provided by Merck:

Biomarkers of muscle anabolism

Study placed in the following topic categories:

Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Methyltestosterone
Hormones
Androgens
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Androgens
Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on August 28, 2009