HealthyPhase 1NCT01017458
Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
A Phase 1 study testing MK0773 and Comparator: testosterone enanthate in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK0773 and Comparator: testosterone enanthate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Aug 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 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is in good general health
- Subject agrees to avoid excess alcohol and strenuous physical activity during the study
- Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study
Who cannot join
- Subject has significant drug allergies
- Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks
- Subject is a regular user or past abuser of any illicit drug (including alcohol)
- Subject drinks excessive amounts of caffeinated beverages
- Subject has a history of cancer
- Subject has a history of prostate or testicular surgery
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
- Conditions
- Healthy
- Being tested
- MK0773, Comparator: testosterone enanthate, Comparator: placebo oral tablet, Comparator: placebo injection
- Keywords
- Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0773Drug
Three 25mg oral tablets MK0773 bid, for 12 weeks
Comparator: testosterone enanthateDrug
Also called Delatestryl
intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks
Comparator: placebo oral tabletDrug
placebo oral tablet bid, for 12 weeks
Comparator: placebo injectionDrug
placebo intramuscular injection q14d, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK0773 + placebo injection Receives: Drug: MK0773; Drug: Comparator: placebo injection |
| 2 | Active comparator | placebo to MK0773 + testosterone injection Receives: Drug: Comparator: testosterone enanthate; Drug: Comparator: placebo oral tablet |
| 3 | Placebo comparator | placebo to MK0773 + placebo injection Receives: Drug: Comparator: placebo oral tablet; Drug: Comparator: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Clinical Adverse Events (CAE)
Measured: 12 weeks
Number of subjects with Serious CAEs
Measured: 12 weeks
Number of subjects with drug-related CAEs
Measured: 12 weeks
Number of subjects with serious drug-related CAEs
Measured: 12 weeks
Number of subjects that discontinued with CAEs
Measured: 12 weeks
Number of subjects with Laboratory Adverse Events (LAE)
Measured: 12 weeks
Number of subjects with drug-related LAEs
Measured: 12 weeks
Number of subjects with serious LAEs
Measured: 12 weeks
Number of subjects with serious drug-related LAEs
Measured: 12 weeks
Number of subjects that discontinued with LAEs
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 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
- NCT01017458
- Sponsor's protocol ID
- 0773-004
- Other IDs
- 2009_693, MK-0773-004
- Status last verified
- Jul 2016
- First submitted
- 18 Nov 2009
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men
- ClinicalTrials.gov ID
- NCT01017458
- Acronym / sponsor ID
- 0773-004
- Conditions
- Healthy
- Keywords
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Nov 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 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK0773, Drug: Comparator: placebo injectionMK0773 + placebo injection |
| 2 | Active comparator | Drug: Comparator: testosterone enanthate, Drug: Comparator: placebo oral tabletplacebo to MK0773 + testosterone injection |
| 3 | Placebo comparator | Drug: Comparator: placebo oral tablet, Drug: Comparator: placebo injectionplacebo to MK0773 + placebo injection |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is in good general health
- Subject agrees to avoid excess alcohol and strenuous physical activity during the study
- Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study
Key exclusion criteria (6 listed)
- Subject has significant drug allergies
- Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks
- Subject is a regular user or past abuser of any illicit drug (including alcohol)
- Subject drinks excessive amounts of caffeinated beverages
- Subject has a history of cancer
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 |
|---|---|---|
| MK0773Three 25mg oral tablets MK0773 bid, for 12 weeks | Drug | 1 |
| Comparator: testosterone enanthateAlso: Delatestrylintramuscular injection 200mg testosterone enanthate q14d, for 12 weeks | Drug | 2 |
| Comparator: placebo oral tabletplacebo oral tablet bid, for 12 weeks | Drug | 2, 3 |
| Comparator: placebo injectionplacebo intramuscular injection q14d, for 12 weeks | Drug | 1, 3 |
Primary outcome
Number of subjects with Clinical Adverse Events (CAE)
Time frame: 12 weeks
Number of subjects with Serious CAEs
Time frame: 12 weeks
Number of subjects with drug-related CAEs
Time frame: 12 weeks
Number of subjects with serious drug-related CAEs
Time frame: 12 weeks
Number of subjects that discontinued with CAEs
Time frame: 12 weeks
Number of subjects with Laboratory Adverse Events (LAE)
Time frame: 12 weeks
Number of subjects with drug-related LAEs
Time frame: 12 weeks
Number of subjects with serious LAEs
Time frame: 12 weeks
Number of subjects with serious drug-related LAEs
Time frame: 12 weeks
Number of subjects that discontinued with LAEs
Time frame: 12 weeks
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 12 Jul 2016.
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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 MK0773 and Comparator: testosterone enanthate in people with Healthy, 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 3 inclusion and 6 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 12 Jul 2016. 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?
Number of subjects with Clinical Adverse Events (CAE) (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2016.