Clinical trial NCT03634969: An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiac Failure
Myocardial Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986224
timeFrame: Up to 11 days
measure: 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
measure: 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
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
timeFrame: Up to 11 days
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986224
timeFrame: Up to 11 days
measure: Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
timeFrame: Up to 11 days
measure: Fraction of unbound drug in plasma (fu) of BMS-986224
timeFrame: Up to 11 days
measure: Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
timeFrame: Up to 11 days
measure: Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
timeFrame: Up to 11 days
measure: Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
timeFrame: 7 days
measure: Fraction of dose excreted in urine (Fe%) of BMS-986224
timeFrame: 7 days
measure: Renal clearance of BMS-986224 derived from urine concentration
timeFrame: 7 days
Secondary outcomes:
measure: Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
timeFrame: Up to 41 days
measure: Maximum observed plasma concentration (Cmax) of metabolite
timeFrame: Up to 11 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite
timeFrame: Up to 11 days
measure: Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite
timeFrame: Up to 11 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite
timeFrame: Up to 11 days
measure: Time of maximum observed plasma concentration (Tmax) of metabolite
timeFrame: Up to 11 days
measure: Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration
timeFrame: Up to 11 days
measure: Metabolite-to-parent (MR) ratio for cMax
timeFrame: Up to 11 days
measure: Metabolite-to-parent (MR) ratio for AUC(0-T)
timeFrame: Up to 11 days
measure: Metabolite-to-parent (MR) ratio for AUC(0-72)
timeFrame: Up to 11 days
measure: Metabolite-to-parent (MR) ratio for AUC(INF)
timeFrame: Up to 11 days
measure: Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests
timeFrame: Up to 11 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Saint Paul
country: United States
facility: Prism Research
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: