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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: CXL-1427 Ascending Dose; Other: Placebo; Drug: CXL-1427 Descending Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02819271

CV013-005 (Other Identifier)

CXL-1427-01

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

CXL-1427 (BMS-986231)

Experimental group

Description:

Experimental

Treatment:

Drug: CXL-1427 Descending Dose

Drug: CXL-1427 Ascending Dose

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo