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

NCT00816712 | Completed Phase 1

• 2 other identifiers: 0000-0642008_604
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Muscle Anabolism

Keywords

Males with low-normal serum total testosterone levels.

Outcome Measures

Primary Outcomes (1)

• Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.

  One week

Secondary Outcomes (1)

• Variability in the muscle fractional synthetic rate measurements.

  One week

Study Arms (3)

A

ACTIVE COMPARATOR

Testosterone - 300 mg IM

Drug: Comparator: Testosterone 300 mg, intramuscular injection

B

ACTIVE COMPARATOR

Testosterone - 100 mg IM

Drug: Comparator: Testosterone 100 mg, Intramuscular injection

C

PLACEBO COMPARATOR

Placebo - IM

Drug: Comparator: Placebo given by Intramuscular Injection

Interventions

Comparator: Testosterone 300 mg, intramuscular injection DRUG

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.

A

Comparator: Testosterone 100 mg, Intramuscular injection DRUG

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.

B

Comparator: Placebo given by Intramuscular Injection DRUG

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.

C

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.

  PMID: 21475673 RESULT

MeSH Terms

Interventions

Injections, Intramuscular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 5, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 13, 2015

Record last verified: 2015-02