Heart Failure
Conditions
Brief summary
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.
Interventions
DRUGCXL-1427 Ascending Dose
OTHERPlacebo
DRUGCXL-1427 Descending Dose
Sponsors
Cardioxyl Pharmaceuticals, Inc
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Terminal elimination half-life (1/2) | Up to 4 days |
| Total body clearance (CL) | Up to 4 days |
| Steady-state plasma concentration (Css) | Up to 4 days |
| Time to Css | Up to 4 days |
| Steady-state volume of distributions (Vss) | Up to 4 days |
| Area under the plasma concentration (AUC) vs. time curve | Up to 4 days |
Outcome results
None listed