Biomarkers of Muscle Anabolism (MK-0000-082)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Muscle Anabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Low dose testosterone

Group Type ACTIVE_COMPARATOR

Comparator: low dose testosterone

Intervention Type DRUG

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

High dose testosterone

Group Type ACTIVE_COMPARATOR

Comparator: high dose testosterone

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes