A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332186
• Other study ID #: CV013-025
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2018
• Est. completion date: October 22, 2018

Study information

• Verified date: September 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Failure
• Congestive Heart Failure
• Heart Failure
• Kidney Failure
• Myocardial Failure
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• BMS-986231
Intravenous infusion administration

Locations

Country	Name	City	State
Czechia	Local Institution	Praha 7
Poland	Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II	Grodzisk Mazowiecki
Poland	Specjalistyczne Centrum Medyczne Panacea Poznan	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) derived from plasma concentration		11 days
Primary	Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration		11 days
Primary	Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration		11 days
Primary	Clearance (CL) derived from plasma concentration		11 days
Primary	Renal clearance (CLR) derived from urine concentration		11 days
Secondary	Number of adverse events (AE)		Up to 31 days
Secondary	Number of serious adverse events (SAE)		Up to 31 days
Secondary	Terminal elimination half-life (t1/2)		Up to 36 hours
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 36 hours
Secondary	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
Secondary	Terminal elimination phase rate constant (?z)		Up to 36 hours
Secondary	Volume of distribution during terminal phase (Vz)		Up to 36 hours
Secondary	Fraction of administered drug excreted into urine (Fe)		Up to 36 hours
Secondary	Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)		Up to 36 hours

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form