Heart Decompensation, AcutePhase 1NCT02932969
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
A Phase 1 study testing BMS-986231 in people with Heart Decompensation, Acute, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Decompensation, Acute
- What is being tested?
- BMS-986231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2016to 26 May 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ancestry
- First generation Japanese
- Non-Asian with grandparents and parents of non-Asian descent
- Body weight greater than or equal to 45kg and less than or equal to 110kg
- Women of childbearing potential have specific birthcontrol methods
- Males sexually active with women of childbearing potential have specific birthcontrol methods
Who cannot join
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials, Llc
Cypress, California, 90630
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants
The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.
- Conditions
- Heart Decompensation, Acute
- Being tested
- BMS-986231, BMS-986231 Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986231Drug
BMS-986231 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Panel 1 Arm | Experimental | BMS-986231 and BMS-986231 Placebo intravenously Receives: Drug: BMS-986231; Drug: BMS-986231 Placebo |
| Panel 2 Arm | Experimental | BMS-986231 and BMS-986231 Placebo intravenously Receives: Drug: BMS-986231; Drug: BMS-986231 Placebo |
| Panel 3 Arm | Experimental | BMS-986231 and BMS-986231 Placebo intravenously Receives: Drug: BMS-986231; Drug: BMS-986231 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start4 Oct 2016
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Decompensation, AcuteStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 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
- NCT02932969
- Sponsor's protocol ID
- CV013-018
- Status last verified
- May 2017
- First submitted
- 12 Oct 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants
- ClinicalTrials.gov ID
- NCT02932969
- Acronym / sponsor ID
- CV013-018
- Conditions
- Heart Decompensation, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 13 Oct 2016 (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 Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel 1 Arm | Experimental | Drug: BMS-986231, Drug: BMS-986231 PlaceboBMS-986231 and BMS-986231 Placebo intravenously |
| Panel 2 Arm | Experimental | Drug: BMS-986231, Drug: BMS-986231 PlaceboBMS-986231 and BMS-986231 Placebo intravenously |
| Panel 3 Arm | Experimental | Drug: BMS-986231, Drug: BMS-986231 PlaceboBMS-986231 and BMS-986231 Placebo intravenously |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ancestry
- Body weight greater than or equal to 45kg and less than or equal to 110kg
- Women of childbearing potential have specific birthcontrol methods
- Males sexually active with women of childbearing potential have specific birthcontrol methods
Key exclusion criteria (5 listed)
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
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-986231 | Drug | Panel 1 Arm, Panel 2 Arm, Panel 3 Arm |
| BMS-986231 Placebo | Drug | Panel 1 Arm, Panel 2 Arm, Panel 3 Arm |
Primary outcome
Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations
Time frame: 11 days
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 31 May 2017.
- Individual participant dataSharing planned: No
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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-986231 in people with Heart Decompensation, Acute, run by Bristol-Myers Squibb at 1 site in United States.
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 6 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 31 May 2017. 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 United States. 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?
Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations (time frame: 11 days). 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 31 May 2017.