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Completed

NCT Number: NCT04237831

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Miami, Florida, United States

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About this study

Recruitment temporarily on hold due to COVID-19

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986259

Drug

Specified Dose on Specified Days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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