Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedStudy Start
First participant enrolled
February 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedApril 9, 2020
April 1, 2020
1 month
January 29, 2020
April 8, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum concentration (Cmax) for BMS-986165 in plasma
Up to 18 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma
Up to 18 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma
Up to 18 days
Secondary Outcomes (10)
Incidence of Adverse Events (AEs)
Up to 23 days
Incidence of Serious Adverse Events (SAEs)
Up to 55 days
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters
Up to 50 days
Number of participants with vital sign abnormalities in body temperature
Up to 50 days
Number of participants with vital sign abnormalities in respiratory rate
Up to 50 days
- +5 more secondary outcomes
Study Arms (4)
Treatment A : BMS-986165
EXPERIMENTALTreatment B: BMS-986165 prototype 1
EXPERIMENTALTreatment C: BMS-986165 prototype 2
EXPERIMENTALTreatment D: BMS-986165 prototype 2
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Sciences Miami
Miami, Florida, 33126, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2020
First Posted
January 30, 2020
Study Start
February 6, 2020
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
April 9, 2020
Record last verified: 2020-04