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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03332186
• Collaborator: (none)
• Enrollment: 48
• Locations: 3
• Arms: 4
• Actual Duration (Months): 7.3
• Patients Per Site: 16
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Failure; Cardiac Failure; Congestive Heart Failure; Kidney Failure; Renal Failure	Drug: BMS-986231	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 15, 2018
• Actual Primary Completion Date: Oct 22, 2018
• Actual Study Completion Date: Oct 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild Renal Impairment Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2	Drug: BMS-986231; Intravenous infusion administration
Experimental: Moderate renal impairment Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2	Drug: BMS-986231; Intravenous infusion administration
Experimental: Severe renal impairment Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis	Drug: BMS-986231; Intravenous infusion administration
Experimental: Normal renal function Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2	Drug: BMS-986231; Intravenous infusion administration

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) derived from plasma concentration [11 days]

2. Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration [11 days]

3. Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration [11 days]

4. Clearance (CL) derived from plasma concentration [11 days]

5. Renal clearance (CLR) derived from urine concentration [11 days]

Secondary Outcome Measures

1. Number of adverse events (AE) [Up to 31 days]

2. Number of serious adverse events (SAE) [Up to 31 days]

3. Terminal elimination half-life (t1/2) [Up to 36 hours]

4. Time of maximum observed plasma concentration (Tmax) [Up to 36 hours]

5. 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]

6. Terminal elimination phase rate constant (λz) [Up to 36 hours]

7. Volume of distribution during terminal phase (Vz) [Up to 36 hours]

8. Fraction of administered drug excreted into urine (Fe) [Up to 36 hours]

9. Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast) [Up to 36 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Praha 7		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

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03332186
• Other Study ID Numbers: CV013-025
• First Posted: Nov 6, 2017
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Renal Insufficiency; Heart Failure

Study Results

No Results Posted as of Sep 11, 2019