OsteoporosisPhase 1NCT01011725
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
A Phase 1 study testing MK 0773 in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- MK 0773
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Mar 2009
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a nonsurgical postmenopausal female
- Subject is neither grossly overweight nor underweight for her height
- Subject is in good health
- Subject is willing to avoid excess alcohol and strenuous physical activity during the study
- Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study
Who cannot join
- Subject has significant drug allergies
- Subject has donated blood or 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
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
- Conditions
- Osteoporosis
- Being tested
- MK 0773, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK 0773Drug
25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
PlaceboDrug
Placebo oral tablet b.i.d for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Women- Active Agent Group | Experimental | Not described Receives: Drug: MK 0773 |
| Postmenopausal Women- Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious Clinical Adverse Events
Measured: From date of enrollment through 12 weeks of study
Number of Participants with Nonerserious Clinical Adverse Events
Measured: From date of enrollment through 12 weeks of study
Number of Participants with Serious Laboratory Adverse Events
Measured: From date of enrollment through 12 weeks of study
Number of Participants with Nonserious Laboratory Adverse Events
Measured: From date of enrollment through 12 weeks of study
Number of Participants Who Discontinued Due to Any Adverse Event
Measured: From date of enrollment through 12 weeks of study
Number of Participants Who Withdrew Consent and Discontinued the Study
Measured: From date of enrollment through 12 weeks of study
Least Squares Mean Change in Lean Body Mass
Measured: From baseline, at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2005
- Primary completionApr 2006
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- 67 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
- NCT01011725
- Sponsor's protocol ID
- 0773-003
- Other IDs
- MK0773-003
- Status last verified
- Feb 2016
- First submitted
- 10 Nov 2009
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01011725
- Acronym / sponsor ID
- 0773-003
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 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 pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Women- Active Agent Group | Experimental | Drug: MK 0773 |
| Postmenopausal Women- Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a nonsurgical postmenopausal female
- Subject is neither grossly overweight nor underweight for her height
- Subject is in good health
- Subject is willing to avoid excess alcohol and strenuous physical activity during the study
- Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study
Key exclusion criteria (5 listed)
- Subject has significant drug allergies
- Subject has donated blood or 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 |
|---|---|---|
| MK 077325 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks | Drug | Postmenopausal Women- Active Agent Group |
| PlaceboPlacebo oral tablet b.i.d for 12 weeks | Drug | Postmenopausal Women- Placebo |
Primary outcome
Number of Participants with Serious Clinical Adverse Events
Time frame: From date of enrollment through 12 weeks of study
Number of Participants with Nonerserious Clinical Adverse Events
Time frame: From date of enrollment through 12 weeks of study
Number of Participants with Serious Laboratory Adverse Events
Time frame: From date of enrollment through 12 weeks of study
Number of Participants with Nonserious Laboratory Adverse Events
Time frame: From date of enrollment through 12 weeks of study
Number of Participants Who Discontinued Due to Any Adverse Event
Time frame: From date of enrollment through 12 weeks of study
Number of Participants Who Withdrew Consent and Discontinued the Study
Time frame: From date of enrollment through 12 weeks of study
Least Squares Mean Change in Lean Body Mass
Time frame: From baseline, at 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 10 Aug 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 MK 0773 in people with Osteoporosis, 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 5 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 10 Aug 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 Participants with Serious Clinical Adverse Events (time frame: From date of enrollment through 12 weeks of study). The study lists 7 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 10 Aug 2016.