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
NCT ID: NCT02819271
Last Updated: 2017-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2014-02-28
2014-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure
NCT02157506
A Dose-Defining Study of CXL-1020 in Patients With Systolic Heart Failure
NCT01096043
Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure
NCT01092325
A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure
NCT07218627
A Study of CK-1827452 Infusion in Stable Heart Failure
NCT00624442
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CXL-1427 (BMS-986231)
Experimental
CXL-1427 Ascending Dose
CXL-1427 Descending Dose
Placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CXL-1427 Ascending Dose
Placebo
CXL-1427 Descending Dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardioxyl Pharmaceuticals, Inc
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cardioxyl Pharmaceuticals
Role: STUDY_DIRECTOR
Cardioxyl Pharmaceuticals
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CV013-005
Identifier Type: OTHER
Identifier Source: secondary_id
CXL-1427-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.