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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Cardioxyl Pharmaceuticals, Inc

Criteria

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