Clinical trial NCT03332186: A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function
Official title: A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Subjects With Varying Degrees of Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myocardial Failure
Cardiac Failure
Congestive Heart Failure
Kidney Failure
Renal Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.


Eligibility 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/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) derived from plasma concentration
timeFrame: 11 days
measure: Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
timeFrame: 11 days
measure: Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
timeFrame: 11 days
measure: Clearance (CL) derived from plasma concentration
timeFrame: 11 days
measure: Renal clearance (CLR) derived from urine concentration
timeFrame: 11 days
Secondary outcomes:
measure: Number of adverse events (AE)
timeFrame: Up to 31 days
measure: Number of serious adverse events (SAE)
timeFrame: Up to 31 days
measure: Terminal elimination half-life (t1/2)
timeFrame: Up to 36 hours
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 36 hours
measure: AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)
timeFrame: Up to 36 hours
measure: Terminal elimination phase rate constant (λz)
timeFrame: Up to 36 hours
measure: Volume of distribution during terminal phase (Vz)
timeFrame: Up to 36 hours
measure: Fraction of administered drug excreted into urine (Fe)
timeFrame: Up to 36 hours
measure: Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)
timeFrame: Up to 36 hours
Other outcomes:
Locations:
city: Praha 7
country: Czechia
facility: Local Institution
city: Grodzisk Mazowiecki
country: Poland
facility: Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
city: Krakow
country: Poland
facility: Specjalistyczne Centrum Medyczne Panacea Poznan
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: