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OpenTrials
Completed

NCT Number: NCT02819271

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CXL-1427 Ascending Dose

Drug

Other names: BMS-986231

Placebo

Other

CXL-1427 Descending Dose

Drug

Other names: BMS-986231

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Cardioxyl Pharmaceuticals, Inc

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2016
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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