CompletedPhase 1

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

United States50 participantsStarted 2018-08-14

Plain-language summary

The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum observed plasma concentration (Cmax) of BMS-986224

Timeframe: Up to 11 days

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224

Timeframe: Up to 11 days

Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224

Timeframe: Up to 11 days

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224

Timeframe: Up to 11 days

Time of maximum observed plasma concentration (Tmax) of BMS-986224

Timeframe: Up to 11 days

Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration

Timeframe: Up to 11 days

Fraction of unbound drug in plasma (fu) of BMS-986224

Trial details

NCT IDNCT03634969

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-30

View on ClinicalTrials.gov More Cardiac Failure trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum observed plasma concentration (Cmax) of BMS-986224

Timeframe: Up to 11 days

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224

Timeframe: Up to 11 days

Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224

Timeframe: Up to 11 days

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224

Timeframe: Up to 11 days

Time of maximum observed plasma concentration (Tmax) of BMS-986224

Timeframe: Up to 11 days

Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration

Timeframe: Up to 11 days

Fraction of unbound drug in plasma (fu) of BMS-986224