BMS-986224
DrugSpecified dose on specified days
Completed
NCT Number: NCT03634969
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.
Completed
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Notify MeKey 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
Loading trial locations.
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
- 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
Treatment and study plan
Primary outcomes
-
Maximum observed plasma concentration (Cmax) of BMS-986224
Time frame: 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
Time frame: 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
Time frame: Up to 11 days
-
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Time frame: Up to 11 days
-
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Time frame: Up to 11 days
-
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
Time frame: Up to 11 days
-
Fraction of unbound drug in plasma (fu) of BMS-986224
Time frame: Up to 11 days
-
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
Time frame: Up to 11 days
-
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
Time frame: Up to 11 days
-
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
Time frame: 7 days
Part 1 only
-
Fraction of dose excreted in urine (Fe%) of BMS-986224
Time frame: 7 days
Part 1 only
-
Renal clearance of BMS-986224 derived from urine concentration
Time frame: 7 days
Part 1 only
Secondary outcomes
-
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time frame: Up to 41 days
-
Maximum observed plasma concentration (Cmax) of metabolite
Time frame: Up to 11 days
-
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite
Time frame: Up to 11 days
-
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite
Time frame: Up to 11 days
-
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite
Time frame: Up to 11 days
-
Time of maximum observed plasma concentration (Tmax) of metabolite
Time frame: Up to 11 days
-
Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration
Time frame: Up to 11 days
-
Metabolite-to-parent (MR) ratio for cMax
Time frame: Up to 11 days
-
Metabolite-to-parent (MR) ratio for AUC(0-T)
Time frame: Up to 11 days
-
Metabolite-to-parent (MR) ratio for AUC(0-72)
Time frame: Up to 11 days
-
Metabolite-to-parent (MR) ratio for AUC(INF)
Time frame: Up to 11 days
-
Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests
Time frame: Up to 11 days
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Aug 17, 2018
- Registry last updated
- Feb 25, 2020
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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