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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

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ClinicalTrials.gov Identifier: NCT02819271
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Cardioxyl Pharmaceuticals, Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: CXL-1427 Ascending Dose Other: Placebo Drug: CXL-1427 Descending Dose Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: CXL-1427 (BMS-986231)
Experimental
Drug: CXL-1427 Ascending Dose
Other Name: BMS-986231
Drug: CXL-1427 Descending Dose
Other Name: BMS-986231
Placebo Comparator: Placebo
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 31 days ]
  2. Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 31 days ]

Secondary Outcome Measures :
  1. Steady-state plasma concentration (Css) [ Time Frame: Up to 4 days ]
  2. Area under the plasma concentration (AUC) vs. time curve [ Time Frame: Up to 4 days ]
  3. Terminal elimination half-life (1/2) [ Time Frame: Up to 4 days ]
  4. Total body clearance (CL) [ Time Frame: Up to 4 days ]
  5. Steady-state volume of distributions (Vss) [ Time Frame: Up to 4 days ]
  6. Time to Css [ Time Frame: Up to 4 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819271


Sponsors and Collaborators
Bristol-Myers Squibb
Cardioxyl Pharmaceuticals, Inc
Investigators
Study Director: Cardioxyl Pharmaceuticals Cardioxyl Pharmaceuticals

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02819271     History of Changes
Other Study ID Numbers: CXL-1427-01
CV013-005 ( Other Identifier: BMS )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases