Major DepressionPhase 1NCT01124344
Safety and Pharmacology Study of BMS-866949
A Phase 1 study testing BMS-866949 in people with Major Depression, run by Bristol-Myers Squibb at 1 site in Sweden.
Trial summary
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- BMS-866949
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Nov 2011
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Panels 1-6: Healthy Male Subjects
- Panel 7: Females
- Ages 21 to 55, inclusive
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Who cannot join
- History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
- History or family history of psychiatric disorder
- Current treatment with prescription medication
- Exposure to any investigational drug or placebo within 12 weeks of study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable
- Conditions
- Major Depression
- Being tested
- Placebo, BMS-866949
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral Solution, Oral, 0 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 3 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 10 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 30 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 45 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 60 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 90 mg, Once Daily, 14 days
BMS-866949Drug
Oral Solution, Oral, 3-60 mg, Once Daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo or BMS-866949 (3 mg) | Active comparator | Panel 1: Healthy Male Subjects Receives: Drug: Placebo; Drug: BMS-866949 |
| Placebo or BMS-866949 (10 mg) | Active comparator | Panel 2: Healthy Male Subjects Receives: Drug: Placebo; Drug: BMS-866949 |
| Placebo or BMS-866949 (30 mg) | Active comparator | Panel 3: Healthy Male Subjects Receives: Drug: Placebo; Drug: BMS-866949 |
| Placebo or BMS-866949 (45 mg) | Active comparator | Panel 4: Healthy Male Subjects Receives: Drug: Placebo; Drug: BMS-866949 |
| Placebo or BMS-866949 (60 mg) | Active comparator | Panel 5: Healthy Male Subjects Receives: Drug: Placebo; Drug: BMS-866949 |
| Placebo or BMS-866949 (90 mg) | Active comparator | Panel 6: Healthy Male Subjects Receives: Drug: Placebo; Drug: BMS-866949 |
| Placebo or BMS-866949 (3 - 60 mg) | Active comparator | Panel 7: Females Receives: Drug: Placebo; Drug: BMS-866949 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety by evaluating incidence of adverse events (AE)
Measured: Over a period of 28 days (+/- 2 days) of first dose
Secondary outcomes (2)
Assessment of pharmacokinetics by evaluating plasma concentration versus time data
Measured: Over a period 28 days (+/- 2 days) of first dose
Assessment of pharmacodynamics by evaluating brain transporter occupancy
Measured: Over a period 28 days (+/- 2 days) of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124344
- Sponsor's protocol ID
- CN166-002
- Other IDs
- 2010-018461-38
- Status last verified
- Mar 2012
- First submitted
- 13 May 2010
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01124344
- Acronym / sponsor ID
- CN166-002
- Conditions
- Major Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 May 2010 (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.
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo or BMS-866949 (3 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 1: Healthy Male Subjects |
| Placebo or BMS-866949 (10 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 2: Healthy Male Subjects |
| Placebo or BMS-866949 (30 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 3: Healthy Male Subjects |
| Placebo or BMS-866949 (45 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 4: Healthy Male Subjects |
| Placebo or BMS-866949 (60 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 5: Healthy Male Subjects |
| Placebo or BMS-866949 (90 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 6: Healthy Male Subjects |
| Placebo or BMS-866949 (3 - 60 mg) | Active comparator | Drug: Placebo, Drug: BMS-866949Panel 7: Females |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Panels 1-6: Healthy Male Subjects
- Panel 7: Females
- Ages 21 to 55, inclusive
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Key exclusion criteria (4 listed)
- History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
- History or family history of psychiatric disorder
- Current treatment with prescription medication
- Exposure to any investigational drug or placebo within 12 weeks of study drug administration
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 |
|---|---|---|
| PlaceboOral Solution, Oral, 0 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (10 mg), Placebo or BMS-866949 (3 - 60 mg), Placebo or BMS-866949 (3 mg), Placebo or BMS-866949 (30 mg), Placebo or BMS-866949 (45 mg), Placebo or BMS-866949 (60 mg), Placebo or BMS-866949 (90 mg) |
| BMS-866949Oral Solution, Oral, 3 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (3 mg) |
| BMS-866949Oral Solution, Oral, 10 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (10 mg) |
| BMS-866949Oral Solution, Oral, 30 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (30 mg) |
| BMS-866949Oral Solution, Oral, 45 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (45 mg) |
| BMS-866949Oral Solution, Oral, 60 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (60 mg) |
| BMS-866949Oral Solution, Oral, 90 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (90 mg) |
| BMS-866949Oral Solution, Oral, 3-60 mg, Once Daily, 14 days | Drug | Placebo or BMS-866949 (3 - 60 mg) |
Primary outcome
Assessment of safety by evaluating incidence of adverse events (AE)
Time frame: Over a period of 28 days (+/- 2 days) of first dose
2 secondary outcomes
Assessment of pharmacokinetics by evaluating plasma concentration versus time data
Time frame: Over a period 28 days (+/- 2 days) of first dose
Assessment of pharmacodynamics by evaluating brain transporter occupancy
Time frame: Over a period 28 days (+/- 2 days) of first dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-866949 in people with Major Depression, run by Bristol-Myers Squibb at 1 site in Sweden.
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 4 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: stopped early, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early. Results are not available in the source record.
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?
Assessment of safety by evaluating incidence of adverse events (AE) (time frame: Over a period of 28 days (+/- 2 days) of first dose). 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 27 Mar 2012.