Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634969
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.

Condition or disease Intervention/treatment Phase
Cardiac Failure Myocardial Failure Drug: BMS-986224 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function
Actual Study Start Date : August 14, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Normal Renal Function Drug: BMS-986224
Specified dose on specified days
Experimental: Mild Renal Impairment Drug: BMS-986224
Specified dose on specified days
Experimental: Moderate Renal Impairment Drug: BMS-986224
Specified dose on specified days
Experimental: Severe Renal Impairment Drug: BMS-986224
Specified dose on specified days
Experimental: End-Stage Renal Disease (ESRD)
ESRD participants and are on chronic hemodialysis
 Drug: BMS-986224
Specified dose on specified days


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986224 [ Time Frame: Up to 11 days ]
  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 [ Time Frame: Up to 11 days ]
  3. Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224 [ Time Frame: Up to 11 days ]
  4. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 [ Time Frame: Up to 11 days ]
  5. Time of maximum observed plasma concentration (Tmax) of BMS-986224 [ Time Frame: Up to 11 days ]
  6. Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration [ Time Frame: Up to 11 days ]
  7. Fraction of unbound drug in plasma (fu) of BMS-986224 [ Time Frame: Up to 11 days ]
  8. Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration [ Time Frame: Up to 11 days ]
  9. Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration [ Time Frame: Up to 11 days ]
  10. Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224 [ Time Frame: 7 days ]
    Part 1 only

  11. Fraction of dose excreted in urine (Fe%) of BMS-986224 [ Time Frame: 7 days ]
    Part 1 only

  12. Renal clearance of BMS-986224 derived from urine concentration [ Time Frame: 7 days ]
    Part 1 only


Secondary Outcome Measures :
  1. Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation [ Time Frame: Up to 41 days ]
  2. Maximum observed plasma concentration (Cmax) of metabolite [ Time Frame: Up to 11 days ]
  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite [ Time Frame: Up to 11 days ]
  4. Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite [ Time Frame: Up to 11 days ]
  5. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite [ Time Frame: Up to 11 days ]
  6. Time of maximum observed plasma concentration (Tmax) of metabolite [ Time Frame: Up to 11 days ]
  7. Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration [ Time Frame: Up to 11 days ]
  8. Metabolite-to-parent (MR) ratio for cMax [ Time Frame: Up to 11 days ]
  9. Metabolite-to-parent (MR) ratio for AUC(0-T) [ Time Frame: Up to 11 days ]
  10. Metabolite-to-parent (MR) ratio for AUC(0-72) [ Time Frame: Up to 11 days ]
  11. Metabolite-to-parent (MR) ratio for AUC(INF) [ Time Frame: Up to 11 days ]
  12. Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests [ Time Frame: Up to 11 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • BMI ≥18 and ≤ 35kg/m2
  • Systolic blood pressure >100 mmHg

Exclusion Criteria:

  • Women of childbearing potential or women who are currently pregnant
  • Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634969


Locations
Layout table for location information
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
Prism Research
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03634969    
Other Study ID Numbers: CV016-010
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases