A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

Study Overview
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Brief Summary
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A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets

Official Title
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A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects

Conditions
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Lupus

Intervention / Treatment
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* Drug: BMS-986165-01
* Drug: BMS-986165 Tablet
* Drug: Famotidine


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-985165-01 prototype formulation 1<br> | Drug: BMS-986165-01<br>* Participants will receive BMS- 986165 -01 in prototype formulation<br>|
| Experimental: BMS-986165 Tablet<br> | Drug: BMS-986165 Tablet<br>* Participants will receive BMS-986165 in tablet form.<br>|
| Experimental: BMS-985165-01 prototype formulation 2<br> | Drug: BMS-986165-01<br>* Participants will receive BMS- 986165 -01 in prototype formulation<br>|
| Experimental: BMS-985165-01 prototype formulation 3<br> | Drug: BMS-986165-01<br>* Participants will receive BMS- 986165 -01 in prototype formulation<br>|
| Experimental: BMS-985165-01 prototype formulation 3 or 4<br> | Drug: BMS-986165-01<br>* Participants will receive BMS- 986165 -01 in prototype formulation<br>Drug: Famotidine<br>* Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine<br>|
| Experimental: BMS-985165-01 prototype formulation 3, 4 or 5<br> | Drug: BMS-986165-01<br>* Participants will receive BMS- 986165 -01 in prototype formulation<br>Drug: Famotidine<br>* Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Concentration observed at 12 hours-(C12) for BMS-986165 |  | Day 1 of treatment | 
| Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy. |  | Approximately 16 weeks | 
| Incidence of serious adverse events (SAE) leading to discontinuation of study therapy. |  | Approximately 16 weeks. | 
| Incidence of adverse events (AEs) leading to discontinuation of study therapy. |  | Approximately 16 weeks. |