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

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: CXL-1427 Ascending Dose; Other: Placebo; Drug: CXL-1427 Descending Dose

• Registration Number: NCT02819271
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Status Verified: 2016-08
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CXL-1427 (BMS-986231)	CXL-1427 Ascending Dose	Experimental
CXL-1427 (BMS-986231)	CXL-1427 Descending Dose	Experimental
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Steady-state volume of distributions (Vss)	Up to 4 days
Time to Css	Up to 4 days
Total body clearance (CL)	Up to 4 days
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