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A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function

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: NCT04237831
Recruitment Status : Active, not recruiting
First Posted : January 23, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

Condition or disease Intervention/treatment Phase
Renal Failure Drug: BMS-986259 Phase 1

Detailed Description:
Recruitment temporarily on hold due to COVID-19

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : February 25, 2021

Arm Intervention/treatment
Experimental: Arm A: Normal Renal Function Drug: BMS-986259
Specified Dose on Specified Days

Experimental: Arm B: Mild Renal Impairment Drug: BMS-986259
Specified Dose on Specified Days

Experimental: Arm C: Moderate Renal Impairment Drug: BMS-986259
Specified Dose on Specified Days

Experimental: Arm D: Severe Renal Impairment Drug: BMS-986259
Specified Dose on Specified Days




Primary Outcome Measures :
  1. Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum [ Time Frame: Day 1 and Day 8 ]
  2. Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum [ Time Frame: Day 1 and Day 8 ]
  3. Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU) [ Time Frame: Day 1 and Day 8 ]
  4. Concentration of BMS-986259 in blood serum at 24 hours (C24) [ Time Frame: Day 1 and Day 8 ]
  5. Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T) [ Time Frame: Day 8 ]
  6. Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax) [ Time Frame: Day 8 ]
  7. Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU]) [ Time Frame: Day 8 ]
  8. Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24) [ Time Frame: Day 8 ]
  9. Terminal elimination half-life of BMS-986259 (T-HALF) [ Time Frame: Day 8 ]
  10. Apparent total clearance of BMS-986259 at steady-state (CLss/F) [ Time Frame: Day 8 ]
  11. Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F) [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Incidence of Non serious Adverse Events (AEs) [ Time Frame: Up to 4 months ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 months ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 months ]
  4. Number of clinically significant changes in vital signs [ Time Frame: Up to 4 months ]
  5. Number in clinically significant changes in Electrocardiogram (ECG) [ Time Frame: Up to 4 months ]
  6. Number of clinically significant changes in physical examinations [ Time Frame: Up to 4 months ]
  7. Number of clinically significant changes in clinical laboratory tests [ Time Frame: Up to 4 months ]


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.


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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:

  • Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
  • No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
  • Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
  • Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
  • Women and men must use highly effective methods of contraception for the duration of treatment

Exclusion Criteria:

  • History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
  • Positive results for drugs abuse in urine/saliva
  • Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
  • Known previous exposure to BMS-986259

Other inclusion/exclusion criteria apply


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): NCT04237831


Locations
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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 Clinical Research
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04237831    
Other Study ID Numbers: CV019-008
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases