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

A First-in-Human Study of the Safety of Single Continuous Intravenous 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Placebo; Drug: CXL-1427 Ascending Dose; Drug: CXL-1427 Descending Dose

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CXL-1427 (BMS-986231); Experimental	Drug: CXL-1427 Ascending Dose; Other Names: BMS-986231; Drug: CXL-1427 Descending Dose; Other Names: BMS-986231
Placebo Comparator: Placebo	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)	Up to 31 days
Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)	Up to 31 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Cardioxyl Pharmaceuticals, Inc
• Investigators: Study Director: Cardioxyl Pharmaceuticals, Cardioxyl Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CXL-1427-01; CV013-005 (Other Identifier: BMS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No