Muscle AnabolismPhase 1NCT00812396
Biomarkers of Muscle Anabolism (MK-0000-082)
A Phase 1 study testing Comparator: low dose testosterone and Comparator: high dose testosterone in people with Muscle Anabolism, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Anabolism
- What is being tested?
- Comparator: low dose testosterone and Comparator: high dose testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Feb 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- subject is a healthy male between 18 and 40 years old
- subject's weight is stable over the past 3 months
- subject agrees to refrain from consuming alcohol during study
- subject agrees to consume no caffeine while in the CRU
- subject agrees to follow meat-free diet
- subject is willing to avoid strenuous activity
- subject has been a nonsmoker for at least 6 months
Who cannot join
- subject is a regular user of illicit drugs
- subject has taken androgenic steroids in the past 12 months
- subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
- subject has prostate cancer
- subject has HIV and/or hepatitis B or C
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism
This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.
- Conditions
- Muscle Anabolism
- Being tested
- Comparator: low dose testosterone, Comparator: high dose testosterone, Comparator: placebo
- Keywords
- Biomarkers of muscle anabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: low dose testosteroneDrug
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
Comparator: high dose testosteroneDrug
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.
Comparator: placeboDrug
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Low dose testosterone Receives: Drug: Comparator: low dose testosterone |
| 2 | Active comparator | High dose testosterone Receives: Drug: Comparator: high dose testosterone |
| 3 | Placebo comparator | Placebo Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparative proteomics on proteins present in the vastus lateralis or plasma
Measured: 1 week
Secondary outcomes (1)
mRNA or miRNA expression in the vastus lateralis or in peripheral blood
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startNov 2007
- Primary completionFeb 2008
- Study completionFeb 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- NCT00812396
- Sponsor's protocol ID
- 0000-082
- Other IDs
- 2008_602
- Status last verified
- Jan 2015
- First submitted
- 19 Dec 2008
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- 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 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism
- ClinicalTrials.gov ID
- NCT00812396
- Acronym / sponsor ID
- 0000-082
- Conditions
- Muscle Anabolism
- Keywords
- Biomarkers of muscle anabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Dec 2008 (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 study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Comparator: low dose testosteroneLow dose testosterone |
| 2 | Active comparator | Drug: Comparator: high dose testosteroneHigh dose testosterone |
| 3 | Placebo comparator | Drug: Comparator: placeboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- subject is a healthy male between 18 and 40 years old
- subject's weight is stable over the past 3 months
- subject agrees to refrain from consuming alcohol during study
- subject agrees to consume no caffeine while in the CRU
- subject agrees to follow meat-free diet
Key exclusion criteria (5 listed)
- subject is a regular user of illicit drugs
- subject has taken androgenic steroids in the past 12 months
- subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
- subject has prostate cancer
- subject has HIV and/or hepatitis B or C
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: low dose testosteroneSubjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone. | Drug | 1 |
| Comparator: high dose testosteroneSubjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone. | Drug | 2 |
| Comparator: placeboSubjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution. | Drug | 3 |
Primary outcome
comparative proteomics on proteins present in the vastus lateralis or plasma
Time frame: 1 week
1 secondary outcome
mRNA or miRNA expression in the vastus lateralis or in peripheral blood
Time frame: 1 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 30 Jan 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: low dose testosterone and Comparator: high dose testosterone 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 7 inclusion and 5 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 30 Jan 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?
comparative proteomics on proteins present in the vastus lateralis or plasma (time frame: 1 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 NCT00812396, 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 30 Jan 2015.