Biomarkers of Muscle Anabolism (MK-0000-082)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Muscle Anabolism

Treatments: Drug: Comparator: placebo; Drug: Comparator: low dose testosterone; Drug: Comparator: high dose testosterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812396

2008_602

0000-082

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Low dose testosterone

Treatment:

Drug: Comparator: low dose testosterone

2

Active Comparator group

Description:

High dose testosterone

Treatment:

Drug: Comparator: high dose testosterone

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo