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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819271
• Other study ID #: CXL-1427-01
• Secondary ID: CV013-005
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2016
• Last updated: January 19, 2017
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• CXL-1427 Ascending Dose

Other:
• Placebo

Drug:
• CXL-1427 Descending Dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Cardioxyl Pharmaceuticals, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)		Up to 31 days
Primary	Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)		Up to 31 days
Secondary	Steady-state plasma concentration (Css)		Up to 4 days
Secondary	Area under the plasma concentration (AUC) vs. time curve		Up to 4 days
Secondary	Terminal elimination half-life (1/2)		Up to 4 days
Secondary	Total body clearance (CL)		Up to 4 days
Secondary	Steady-state volume of distributions (Vss)		Up to 4 days
Secondary	Time to Css		Up to 4 days

External Links

•   FDA Safety Alerts and Recalls