Biomarkers of Muscle Anabolism (MK-0000-082)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00812396
First received: December 19, 2008
Last updated: February 20, 2014
Last verified: February 2014
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
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 Sharp & Dohme Corp.:

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: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Active Comparator: 2
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.
Placebo Comparator: 3
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subject is a healthy male between 18 and 40 years old
  • subject's weight is stable over the past 3 months
  • subject agrees to refrain from consuming alcohol during study
  • subject agrees to consume no caffeine while in the CRU
  • subject agrees to follow meat-free diet
  • subject is willing to avoid strenuous activity
  • subject has been a nonsmoker for at least 6 months

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00812396     History of Changes
Other Study ID Numbers: 0000-082, 2008_602
Study First Received: December 19, 2008
Last Updated: February 20, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Merck Sharp & Dohme Corp.:
Biomarkers of muscle anabolism

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 23, 2014