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

• ClinicalTrials.gov Identifier: NCT00816712
• Recruitment Status: Completed
• First Posted: January 5, 2009
• Last Update Posted: February 13, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Muscle Anabolism	Drug: Comparator: Testosterone 300 mg, intramuscular injection; Drug: Comparator: Testosterone 100 mg, Intramuscular injection; Drug: Comparator: Placebo given by Intramuscular Injection	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR)
• Study Start Date: January 2008
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A; Testosterone - 300 mg IM	Drug: Comparator: Testosterone 300 mg, intramuscular injection; Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Testosterone 300 mg, Intramuscular injection.
Active Comparator: B; Testosterone - 100 mg IM	Drug: Comparator: Testosterone 100 mg, Intramuscular injection; Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Testosterone 100 mg, Intramuscular injection.
Placebo Comparator: C; Placebo - IM	Drug: Comparator: Placebo given by Intramuscular Injection; Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Placebo given as intramuscular injection.

Outcome Measures

Primary Outcome Measures :

1. Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone. [ Time Frame: One week ]

Secondary Outcome Measures :

1. Variability in the muscle fractional synthetic rate measurements. [ Time Frame: One week ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. Epub 2011 Feb 26.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00816712
• Other Study ID Numbers: 0000-064; 2008_604
• First Posted: January 5, 2009
• Last Update Posted: February 13, 2015
• Last Verified: February 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Males with low-normal serum total testosterone levels.

Additional relevant MeSH terms:

Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anabolic Agents