Biomarkers of Muscle Anabolism (MK-0000-082)

Muscle Anabolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812396
• Other study ID #: 0000-082
• Secondary ID: 2008_602
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: January 29, 2015
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Muscle Anabolism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparative proteomics on proteins present in the vastus lateralis or plasma		1 week	No
Secondary	mRNA or miRNA expression in the vastus lateralis or in peripheral blood		1 week	No