Biomarkers of Muscle Anabolism (MK-0000-082)

Phase 1CompletedNCT00812396

Merck Sharp & Dohme LLC30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Muscle Anabolism

Interventions

Comparator: low dose testosteroneDRUG

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 testosteroneDRUG

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: placeboDRUG

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

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

comparative proteomics on proteins present in the vastus lateralis or plasma

Time frame: 1 week

Secondary Outcomes

mRNA or miRNA expression in the vastus lateralis or in peripheral blood

Time frame: 1 week

Data from ClinicalTrials.gov

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