Clinical trial NCT04249284: Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Official title: A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
* Body weight \>= 50 kg at screening
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
* Inability to tolerate oral medication
* History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum concentration (Cmax) for BMS-986165 in plasma
timeFrame: Up to 18 days
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma
timeFrame: Up to 18 days
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma
timeFrame: Up to 18 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 23 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 55 days
measure: Number of clinically significant abnormalities in electrocardiogram (ECG) parameters
timeFrame: Up to 50 days
measure: Number of participants with vital sign abnormalities in body temperature
timeFrame: Up to 50 days
measure: Number of participants with vital sign abnormalities in respiratory rate
timeFrame: Up to 50 days
measure: Number of participants with vital sign abnormalities in heart rate
timeFrame: Up to 50 days
measure: Number of participants with vital sign abnormalities in blood pressure
timeFrame: Up to 50 days
measure: Number of participants with clinical laboratory test abnormalities: Hematology tests
timeFrame: Up to 50 days
measure: Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests
timeFrame: Up to 50 days
measure: Number of participants with clinical laboratory test abnormalities: Urinalysis tests
timeFrame: Up to 50 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: