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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

This study has been completed.
Cardioxyl Pharmaceuticals, Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: June 28, 2016
Last updated: January 19, 2017
Last verified: August 2016
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: February 2014
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CXL-1427 (BMS-986231)
Drug: CXL-1427 Ascending Dose
Other Name: BMS-986231
Drug: CXL-1427 Descending Dose
Other Name: BMS-986231
Placebo Comparator: Placebo
Other: Placebo


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

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT02819271

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

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT02819271     History of Changes
Other Study ID Numbers: CXL-1427-01
CV013-005 ( Other Identifier: BMS )
Study First Received: June 28, 2016
Last Updated: January 19, 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017