Cardiac Failure, Congestive Heart Failure, Kidney Failure, Myocardial Failure, Renal Failure
Conditions
Brief summary
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
Interventions
DRUGBMS-986231
Intravenous infusion administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Body weight ≥ 45 kg and ≤ 120 kg * BMI ≥ 18 kg/m\^2 and ≤ 35 kg/m\^2 * Heart rate ≥ 50 bpm and \< 95 bpm * Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment * No changes in medication within 30 days prior to study drug administration
Exclusion criteria
* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests * History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months * History of headaches related to caffeine withdrawal * History of migraine or cluster headaches * Patients requiring dialysis will not be enrolled in this study Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) derived from plasma concentration | 11 days |
| Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration | 11 days |
| Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration | 11 days |
| Clearance (CL) derived from plasma concentration | 11 days |
| Renal clearance (CLR) derived from urine concentration | 11 days |
Secondary
| Measure | Time frame |
|---|---|
| Terminal elimination phase rate constant (λz) | Up to 36 hours |
| Volume of distribution during terminal phase (Vz) | Up to 36 hours |
| Number of adverse events (AE) | Up to 31 days |
| Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast) | Up to 36 hours |
| Fraction of administered drug excreted into urine (Fe) | Up to 36 hours |
| Number of serious adverse events (SAE) | Up to 31 days |
| Terminal elimination half-life (t1/2) | Up to 36 hours |
| Time of maximum observed plasma concentration (Tmax) | Up to 36 hours |
| AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt) | Up to 36 hours |
Countries
Czechia, Poland
Outcome results
None listed