A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
1 other identifier
interventional
33
1 country
1
Brief Summary
A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2019
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
August 22, 2019
CompletedStudy Start
First participant enrolled
August 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedJanuary 6, 2021
January 1, 2021
4 months
August 21, 2019
January 5, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax) for BMS-986165
Day 1 of treatment
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165
Day 1 of treatment
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165
Day 1 of treatment
Secondary Outcomes (9)
Time to maximum observed plasma concentration-(Tmax) for BMS -986165
Day 1 of treatment
Apparent plasma elimination half-life- (T-HALF) for BMS-986165
Day 1 of treatment
Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165
Day 1 of treatment
Apparent clearance -(CL/F) for BMS-986165
Day 1 of treatment
Concentration observed at 24 hours-(C24) for BMS-986165
Day 1 of treatment
- +4 more secondary outcomes
Study Arms (6)
BMS-985165-01 prototype formulation 1
EXPERIMENTALBMS-986165 Tablet
EXPERIMENTALBMS-985165-01 prototype formulation 2
EXPERIMENTALBMS-985165-01 prototype formulation 3
EXPERIMENTALBMS-985165-01 prototype formulation 3 or 4
EXPERIMENTALBMS-985165-01 prototype formulation 3, 4 or 5
EXPERIMENTALInterventions
Participants will receive BMS- 986165 -01 in prototype formulation
Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
Eligibility Criteria
You may qualify if:
- Patients must be willing and able to complete all study-specific procedures and visits
- Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
- Normal renal function at screening
You may not qualify if:
- History or presence of chronic bacterial, viral infection, or autoimmune disorder
- Active TB requiring treatment or documented latent TB within the previous 3 years
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Sciences
Nottingham, NG11 6JS, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2019
First Posted
August 22, 2019
Study Start
August 22, 2019
Primary Completion
December 8, 2019
Study Completion
December 10, 2019
Last Updated
January 6, 2021
Record last verified: 2021-01