OsteoporosisPhase 1NCT00863590
A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers
A Phase 1 study testing odanacatib, Comparator: odanacatib (Panel B) and Comparator: odanacatib (Panel C) in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- odanacatib, Comparator: odanacatib (Panel B) and Comparator: odanacatib (Panel C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in good health
- Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
- Female subject is postmenopausal
- Subject is within 20% of ideal body weight
- Subject is a nonsmoker
Who cannot join
- Subject has multiple or severe allergies to food or medications
- Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
- Subject has any infections, including HIV
- Subject consumes excessive amounts of caffeine or alcohol
- Subject has donated blood or taken another investigational drug in the last month
- Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers
This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.
- Conditions
- Osteoporosis
- Being tested
- odanacatib, Comparator: odanacatib (Panel B), Comparator: odanacatib (Panel C), Comparator: odanacatib (Panel D)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
odanacatibDrug
[Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
Comparator: odanacatib (Panel B)Drug
Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
Comparator: odanacatib (Panel C)Drug
Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.
Comparator: odanacatib (Panel D)Drug
Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Panel A Receives: Drug: odanacatib |
| B | Experimental | Panel B Receives: Drug: Comparator: odanacatib (Panel B) |
| C | Experimental | Panel C Receives: Drug: Comparator: odanacatib (Panel C) |
| D | Experimental | Panel D Receives: Drug: Comparator: odanacatib (Panel D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability based on assessment of clinical and laboratory adverse experiences
Measured: Part I: 12 Weeks, Part II: 13 Weeks
Secondary outcomes (1)
Plasma concentration of MK0822
Measured: Up to 336 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startJun 2004
- Primary completionFeb 2005
- Study completionAug 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 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
- 24 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
- NCT00863590
- Sponsor's protocol ID
- 0822-001
- Other IDs
- 2009_562
- Status last verified
- Aug 2015
- First submitted
- 16 Mar 2009
- Last updated
- 19 Aug 2015
- Results posted
- No
Publications
Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.
PubMed 23013236
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00863590
- Acronym / sponsor ID
- 0822-001
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Mar 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 assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: odanacatibPanel A |
| B | Experimental | Drug: Comparator: odanacatib (Panel B)Panel B |
| C | Experimental | Drug: Comparator: odanacatib (Panel C)Panel C |
| D | Experimental | Drug: Comparator: odanacatib (Panel D)Panel D |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is in good health
- Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
- Female subject is postmenopausal
- Subject is within 20% of ideal body weight
- Subject is a nonsmoker
Key exclusion criteria (6 listed)
- Subject has multiple or severe allergies to food or medications
- Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
- Subject has any infections, including HIV
- Subject consumes excessive amounts of caffeine or alcohol
- Subject has donated blood or taken another investigational drug in the last month
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 |
|---|---|---|
| odanacatib[Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period. | Drug | A |
| Comparator: odanacatib (Panel B)Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period. | Drug | B |
| Comparator: odanacatib (Panel C)Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period. | Drug | C |
| Comparator: odanacatib (Panel D)Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period. | Drug | D |
Primary outcome
safety and tolerability based on assessment of clinical and laboratory adverse experiences
Time frame: Part I: 12 Weeks, Part II: 13 Weeks
1 secondary outcome
Plasma concentration of MK0822
Time frame: Up to 336 hours postdose
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 19 Aug 2015.
- Results publication: PubMed 23013236Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.
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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 odanacatib, Comparator: odanacatib (Panel B) and Comparator: odanacatib (Panel C) 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 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 19 Aug 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. 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?
safety and tolerability based on assessment of clinical and laboratory adverse experiences (time frame: Part I: 12 Weeks, Part II: 13 Weeks). 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 NCT00863590, 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 19 Aug 2015.