DepressionPhase 1NCT00949767
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
A Phase 1 study testing BMS-866949 in people with Depression, run by Bristol-Myers Squibb at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 64 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2009to Mar 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male 18-55
- Women not of child bearing potential, 18-55
Who cannot join
- History of or current treatment for psychiatric illnesses, substance abuse or dependence
- History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.
- Conditions
- Depression
- Being tested
- BMS-866949, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-866949Drug
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
BMS-866949Drug
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
BMS-866949Drug
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
BMS-866949Drug
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
BMS-866949Drug
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
BMS-866949Drug
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
BMS-866949Drug
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
PlaceboDrug
(Matching volume) - Oral Solution, Oral, once 14 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-866949 (Panel 1) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
| BMS-866949 (Panel 2) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
| BMS-866949 (Panel 3) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
| BMS-866949 (Panel 4) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
| BMS-866949 (Panel 5) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
| BMS-866949 (Panel 6) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
| BMS-866949 (Panel 7) | Experimental | Not described Receives: Drug: BMS-866949; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
Measured: up to Day 14 +/- 2 days post-dose
Secondary outcomes (1)
Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples
Measured: Blood samples will be taken up to 144 hour post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949767
- Sponsor's protocol ID
- CN166-001
- Other IDs
- EUDRACT # is 2009-010220-26
- Status last verified
- Mar 2010
- First submitted
- 29 Jul 2009
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00949767
- Acronym / sponsor ID
- CN166-001
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jul 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.
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BMS-866949 (Panel 1) | Experimental | Drug: BMS-866949, Drug: Placebo |
| BMS-866949 (Panel 2) | Experimental | Drug: BMS-866949, Drug: Placebo |
| BMS-866949 (Panel 3) | Experimental | Drug: BMS-866949, Drug: Placebo |
| BMS-866949 (Panel 4) | Experimental | Drug: BMS-866949, Drug: Placebo |
| BMS-866949 (Panel 5) | Experimental | Drug: BMS-866949, Drug: Placebo |
| BMS-866949 (Panel 6) | Experimental | Drug: BMS-866949, Drug: Placebo |
| BMS-866949 (Panel 7) | Experimental | Drug: BMS-866949, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male 18-55
- Women not of child bearing potential, 18-55
Key exclusion criteria (2 listed)
- History of or current treatment for psychiatric illnesses, substance abuse or dependence
- History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)
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 |
|---|---|---|
| BMS-866949(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 1) |
| BMS-866949(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 2) |
| BMS-866949(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 3) |
| BMS-866949(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 4) |
| BMS-866949(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 5) |
| BMS-866949(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 6) |
| BMS-866949(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days | Drug | BMS-866949 (Panel 7) |
| Placebo(Matching volume) - Oral Solution, Oral, once 14 days | Drug | BMS-866949 (Panel 1), BMS-866949 (Panel 2), BMS-866949 (Panel 3), BMS-866949 (Panel 4), BMS-866949 (Panel 5), BMS-866949 (Panel 6), BMS-866949 (Panel 7) |
Primary outcome
Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
Time frame: up to Day 14 +/- 2 days post-dose
1 secondary outcome
Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples
Time frame: Blood samples will be taken up to 144 hour post-dose
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 25 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 2 inclusion and 2 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 25 Jan 2011. 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 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?
Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs (time frame: up to Day 14 +/- 2 days post-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 25 Jan 2011.