A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Subject is weight stable over the past 3 months

• Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study

• Subject agrees to follow the study restriction of no caffeine while on study

• Patient agrees to following the meat-free controlled protein weight-maintaining diet

• Patient is willing to avoid strenuous physical activity

• Patient has been a nonsmoker for at least 6 months prior to study start

Exclusion Criteria:

• Subject is currently a regular user of any illicit drugs

• Subject has taken androgenic steroids in the previous 12 months

• Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month

• Subject has prostate cancer

• Subject has a history of cancer except basal-cell tumors

• Subject has been diagnosed with HIV

• Subject has been diagnosed with Hepatitis B or C

• Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib

• Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin

• Subject is currently taking over the counter supplements such as "muscle builders" or "fat burners"

• Subject has an allergy or hypersensitivity to intramuscular testosterone

• Subject has sciatica

• Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent

• Subject has undergone a surgical procedure within 1 month of signing informed consent

• Subject is currently participating or has participated in a study with an investigational drug or device