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
2 other identifiers
interventional
80
0 countries
N/A
Brief Summary
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 heart-failure
Started Feb 2014
Shorter than P25 for phase_1 heart-failure
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedJanuary 23, 2017
August 1, 2016
2 months
June 28, 2016
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
CXL-1427 (BMS-986231)
EXPERIMENTALExperimental
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Cardioxyl Pharmaceuticals, Inccollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cardioxyl Pharmaceuticals
Cardioxyl Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
June 30, 2016
Study Start
February 1, 2014
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
January 23, 2017
Record last verified: 2016-08