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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Muscle Anabolism

Treatments: Drug: Comparator: Placebo given by Intramuscular Injection; Drug: Comparator: Testosterone 100 mg, Intramuscular injection; Drug: Comparator: Testosterone 300 mg, intramuscular injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00816712

0000-064

2008_604

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 60 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

Testosterone - 300 mg IM

Treatment:

Drug: Comparator: Testosterone 300 mg, intramuscular injection

B

Active Comparator group

Description:

Testosterone - 100 mg IM

Treatment:

Drug: Comparator: Testosterone 100 mg, Intramuscular injection

C

Placebo Comparator group

Description:

Placebo - IM

Treatment:

Drug: Comparator: Placebo given by Intramuscular Injection