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

Muscle Anabolism Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816712
• Other study ID #: 0000-064
• Secondary ID: 2008_604
• Status: Completed
• Phase: Phase 1
• First received: December 31, 2008
• Last updated: February 12, 2015
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Anabolism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.		One week	No
Secondary	Variability in the muscle fractional synthetic rate measurements.		One week	No