Heart FailurePhase 1NCT02819271
A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
A Phase 1 study testing CXL-1427 Ascending Dose and CXL-1427 Descending Dose in people with Heart Failure, run by Bristol-Myers Squibb.
Trial summary
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- CXL-1427 Ascending Dose and CXL-1427 Descending Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Apr 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No evidence of any acute or chronic health disorder
- Not have taken any prescription medication within 15 days of study entry
- Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
- Not have not have any dietary restrictions
- Have a body mass index (BMI) of ≥18 to ≤34
- Weigh at least 50kg (110 pounds)
Who cannot join
- Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
- Have a history of symptomatic hypotension, orthostatic hypotension or syncope
- Have a history of headaches or other symptoms attributable to caffeine withdrawal
- Have a history of any bleeding diathesis
- Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening
- Other protocol defined inclusion/exclusion criteria could apply
About this study
Official title: A First-in-Human Study of the Safety of Single Continuous Intravenous Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.
- Conditions
- Heart Failure
- Being tested
- CXL-1427 Ascending Dose, Placebo, CXL-1427 Descending Dose
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXL-1427 Ascending DoseDrug
Also called BMS-986231
PlaceboOther
CXL-1427 Descending DoseDrug
Also called BMS-986231
| Study group | Role | What they receive |
|---|---|---|
| CXL-1427 (BMS-986231) | Experimental | Experimental Receives: Drug: CXL-1427 Ascending Dose; Drug: CXL-1427 Descending Dose |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 31 days
Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 31 days
Secondary outcomes (6)
Steady-state plasma concentration (Css)
Measured: Up to 4 days
Area under the plasma concentration (AUC) vs. time curve
Measured: Up to 4 days
Terminal elimination half-life (1/2)
Measured: Up to 4 days
Total body clearance (CL)
Measured: Up to 4 days
Steady-state volume of distributions (Vss)
Measured: Up to 4 days
Time to Css
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardioxyl Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Cardioxyl Pharmaceuticals, Study director, Cardioxyl Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819271
- Sponsor's protocol ID
- CXL-1427-01
- Other IDs
- CV013-005
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of the Safety of Single Continuous Intravenous Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02819271
- Acronym / sponsor ID
- CXL-1427-01
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Cardioxyl Pharmaceuticals, Inc
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jun 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.
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXL-1427 (BMS-986231) | Experimental | Drug: CXL-1427 Ascending Dose, Drug: CXL-1427 Descending DoseExperimental |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- No evidence of any acute or chronic health disorder
- Not have taken any prescription medication within 15 days of study entry
- Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
- Not have not have any dietary restrictions
- Have a body mass index (BMI) of ≥18 to ≤34
Key exclusion criteria (6 listed)
- Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
- Have a history of symptomatic hypotension, orthostatic hypotension or syncope
- Have a history of headaches or other symptoms attributable to caffeine withdrawal
- Have a history of any bleeding diathesis
- Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening
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 |
|---|---|---|
| CXL-1427 Ascending DoseAlso: BMS-986231 | Drug | CXL-1427 (BMS-986231) |
| Placebo | Other | Placebo |
| CXL-1427 Descending DoseAlso: BMS-986231 | Drug | CXL-1427 (BMS-986231) |
Primary outcome
Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 31 days
Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 31 days
6 secondary outcomes
Steady-state plasma concentration (Css)
Time frame: Up to 4 days
Area under the plasma concentration (AUC) vs. time curve
Time frame: Up to 4 days
Terminal elimination half-life (1/2)
Time frame: Up to 4 days
Total body clearance (CL)
Time frame: Up to 4 days
Steady-state volume of distributions (Vss)
Time frame: Up to 4 days
Time to Css
Time frame: Up to 4 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 23 Jan 2017.
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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.
Cardioxyl Pharmaceuticals study director
Cardioxyl Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CXL-1427 Ascending Dose and CXL-1427 Descending Dose in people with Heart Failure, run by Bristol-Myers Squibb.
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 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 23 Jan 2017. 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. Some participants in this study may receive a placebo. 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 measured by percentage of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 31 days). The study lists 2 primary outcomes in all. 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 23 Jan 2017.