DepressionPhase 1NCT00964912
Single Dose Study of BMS-820836
A Phase 1 study testing BMS-820836 in people with Depression, run by Bristol-Myers Squibb at 1 site in Canada.
Trial summary
The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses 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-820836
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
- Right-handed, non-ambidextrous subjects for Part 2
- Men and women, ages 18 to 55 years, inclusive
Who cannot join
- Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- WOCBP using a prohibited contraceptive method
- Women who are pregnant or breastfeeding
- Sexually active fertile men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
Show all 24Show fewer
- History of cholecystectomy
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact the absorption of study drug
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
- Blood transfusion within 4 weeks of study drug administration
- Inability to tolerate/swallow oral medication
- Difficulty with venipuncture and/or poor venous access
- Self-reported smokers
- Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
- Confirmed resting supine systolic blood pressure > 130 mmHg
- Confirmed resting supine diastolic blood pressure > 80 mmHg
- Confirmed QT value ≥ 500 msec
- Confirmed QTc (Bazett) value ≥ 450 msec
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History of peppermint allergies
- History of brain conditions (e.g. history of stroke, head trauma, etc.)
- History of or current psychiatric conditions
- History of claustrophobia
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-820836 in Healthy Subjects
The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses
- Conditions
- Depression
- Being tested
- BMS-820836, 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-820836Drug
Oral Solution, Oral, 0.025 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 0.1 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 0.25 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 0.5 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 1 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 2 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 3 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 5 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 8 mg, single dose, one dose
PlaceboDrug
Oral Solution, Oral, 0 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 3 mg, single dose, one dose
BMS-820836Drug
Oral Solution, Oral, 0.5 mg, single dose, one dose
| Study group | Role | What they receive |
|---|---|---|
| BMS-820836 (Part 1, Panel 1) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 2) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 3) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 4) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 5) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 6) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 7) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 8) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 1, Panel 9) | Active comparator | Not described Receives: Drug: BMS-820836; Drug: Placebo |
| BMS-820836 (Part 2, Panel A) | Active comparator | Not described Receives: Drug: BMS-820836 |
| BMS-820836 (Part 2, Panel B) | Active comparator | Not described Receives: Drug: BMS-820836 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of BMS-820836 following single-dose administration
Measured: Within 14 days of first dose
Secondary outcomes (2)
To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007
Measured: Within 7 days of dosing
To assess the pharmacodynamics of BMS-820836
Measured: Within 48 hours of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964912
- Sponsor's protocol ID
- CN162-001
- Status last verified
- Jan 2011
- First submitted
- 24 Aug 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-820836 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00964912
- Acronym / sponsor ID
- CN162-001
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Aug 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 determine the safety and tolerability of BMS-820836 after single doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| BMS-820836 (Part 1, Panel 1) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 2) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 3) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 4) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 5) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 6) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 7) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 8) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 1, Panel 9) | Active comparator | Drug: BMS-820836, Drug: Placebo |
| BMS-820836 (Part 2, Panel A) | Active comparator | Drug: BMS-820836 |
| BMS-820836 (Part 2, Panel B) | Active comparator | Drug: BMS-820836 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
- Right-handed, non-ambidextrous subjects for Part 2
- Men and women, ages 18 to 55 years, inclusive
Key exclusion criteria (24 listed)
- Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- WOCBP using a prohibited contraceptive method
- Women who are pregnant or breastfeeding
- Sexually active fertile men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
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-820836Oral Solution, Oral, 0.025 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 1) |
| BMS-820836Oral Solution, Oral, 0.1 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 2) |
| BMS-820836Oral Solution, Oral, 0.25 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 3) |
| BMS-820836Oral Solution, Oral, 0.5 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 4) |
| BMS-820836Oral Solution, Oral, 1 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 5) |
| BMS-820836Oral Solution, Oral, 2 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 6) |
| BMS-820836Oral Solution, Oral, 3 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 7) |
| BMS-820836Oral Solution, Oral, 5 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 8) |
| BMS-820836Oral Solution, Oral, 8 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 9) |
| PlaceboOral Solution, Oral, 0 mg, single dose, one dose | Drug | BMS-820836 (Part 1, Panel 1), BMS-820836 (Part 1, Panel 2), BMS-820836 (Part 1, Panel 3), BMS-820836 (Part 1, Panel 4), BMS-820836 (Part 1, Panel 5), BMS-820836 (Part 1, Panel 6), BMS-820836 (Part 1, Panel 7), BMS-820836 (Part 1, Panel 8), BMS-820836 (Part 1, Panel 9) |
| BMS-820836Oral Solution, Oral, 3 mg, single dose, one dose | Drug | BMS-820836 (Part 2, Panel A) |
| BMS-820836Oral Solution, Oral, 0.5 mg, single dose, one dose | Drug | BMS-820836 (Part 2, Panel B) |
Primary outcome
To assess the safety and tolerability of BMS-820836 following single-dose administration
Time frame: Within 14 days of first dose
2 secondary outcomes
To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007
Time frame: Within 7 days of dosing
To assess the pharmacodynamics of BMS-820836
Time frame: Within 48 hours of dosing
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.
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-820836 in people with Depression, run by Bristol-Myers Squibb at 1 site in Canada.
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 24 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 Canada. 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?
To assess the safety and tolerability of BMS-820836 following single-dose administration (time frame: Within 14 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 25 Jan 2011.