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Trial record 1 of 5 for:    cardioxyl
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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.
Sponsor:
Collaborator:
Cardioxyl Pharmaceuticals, Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02819271
First received: June 28, 2016
Last updated: January 19, 2017
Last verified: August 2016
  Purpose
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)
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

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02819271

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

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 )
Study First Received: June 28, 2016
Last Updated: January 19, 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 25, 2017