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 range18 Years – 80 Years

SexALL

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

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

Timeframe: Up to 11 days

Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration

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 range18 Years – 80 Years

SexALL

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

Timeframe: Up to 11 days

Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration