Status:
COMPLETED
A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myocardial Failure
Cardiac Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03332186
Start Date
March 15 2018
End Date
October 22 2018
Last Update
September 11 2019
Active Locations (3)
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1
Local Institution
Prague, Czechia, 170 00
2
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, Poland, 05-825
3
Specjalistyczne Centrum Medyczne Panacea Poznan
Krakow, Poland, 31-559