Muscle AnabolismPhase 1NCT00816712
A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)
A Phase 1 study testing Comparator: Testosterone 300 mg, intramuscular injection and Comparator: Testosterone 100 mg, Intramuscular injection in people with Muscle Anabolism, run by Merck Sharp & Dohme LLC.
Trial summary
This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up). Read more about this study
- Who is it for?
- Ages 60 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Anabolism
- What is being tested?
- Comparator: Testosterone 300 mg, intramuscular injection and Comparator: Testosterone 100 mg, Intramuscular injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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)
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
- Being tested
- Comparator: Testosterone 300 mg, intramuscular injection, Comparator: Testosterone 100 mg, Intramuscular injection, Comparator: Placebo given by Intramuscular Injection
- Keywords
- Males with low-normal serum total testosterone levels.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: Testosterone 300 mg, intramuscular injectionDrug
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 injectionDrug
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 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Testosterone - 300 mg IM Receives: Drug: Comparator: Testosterone 300 mg, intramuscular injection |
| B | Active comparator | Testosterone - 100 mg IM Receives: Drug: Comparator: Testosterone 100 mg, Intramuscular injection |
| C | Placebo comparator | Placebo - IM Receives: Drug: Comparator: Placebo given by Intramuscular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.
Measured: One week
Secondary outcomes (1)
Variability in the muscle fractional synthetic rate measurements.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle AnabolismStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816712
- Sponsor's protocol ID
- 0000-064
- Other IDs
- 2008_604
- Status last verified
- Feb 2015
- First submitted
- 31 Dec 2008
- Last updated
- 13 Feb 2015
- Results posted
- No
Publications
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.
PubMed 21475673
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00816712
- Acronym / sponsor ID
- 0000-064
- Conditions
- Muscle Anabolism
- Keywords
- Males with low-normal serum total testosterone levels.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Comparator: Testosterone 300 mg, intramuscular injectionTestosterone - 300 mg IM |
| B | Active comparator | Drug: Comparator: Testosterone 100 mg, Intramuscular injectionTestosterone - 100 mg IM |
| C | Placebo comparator | Drug: Comparator: Placebo given by Intramuscular InjectionPlacebo - IM |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: Testosterone 300 mg, intramuscular injectionDay 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. | Drug | A |
| Comparator: Testosterone 100 mg, Intramuscular injectionDay 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. | Drug | B |
| Comparator: Placebo given by Intramuscular InjectionDay 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. | Drug | C |
Primary outcome
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.
Time frame: One week
1 secondary outcome
Variability in the muscle fractional synthetic rate measurements.
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Results publication: PubMed 21475673Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: Testosterone 300 mg, intramuscular injection and Comparator: Testosterone 100 mg, Intramuscular injection in people with Muscle Anabolism, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone. (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00816712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.