A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

Study Overview
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Brief Summary
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The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.

Official Title
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A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BMS-986166
* Drug: Placebo matching BMS-986166


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: Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations Ages 18 to 55 years Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause Exclusion Criteria: Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study Other protocol defined inclusion/exclusion criteria could apply

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Panel 1<br>BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified | Drug: BMS-986166<br> <br> Drug: Placebo matching BMS-986166<br> <br> |
| Experimental: Dose Panel 2<br>BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified | Drug: BMS-986166<br> <br> Drug: Placebo matching BMS-986166<br> <br> |
| Experimental: Dose Panel 3<br>BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified | Drug: BMS-986166<br> <br> Drug: Placebo matching BMS-986166<br> <br> |
| Experimental: Dose Panel 4<br>BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified | Drug: BMS-986166<br> <br> Drug: Placebo matching BMS-986166<br> <br> |
| Experimental: Dose Panel 5a/b/c<br>BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions | Drug: BMS-986166<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of All Adverse Events (AEs) |  | Baseline Day -1 to Day 65 | 
| Incidence of Serious Adverse Events (SAEs) |  | Baseline Day -1 to Day 65 | 
| Severity of all All Adverse Events (AEs) |  | Baseline Day -1 to Day 65 | 
| Change from baseline in electrocardiogram(ECG) results |  | Baseline Day -1 to Day 35 | 
| Change from baseline in body temperature |  | Baseline Day -1 to Day 35 | 
| Change from baseline in respiratory rate |  | Baseline Day -1 to Day 35 | 
| Change from baseline in seated blood pressure |  | Baseline Day -1 to Day 35 | 
| Change from baseline in heart rate |  | Baseline Day -1 to Day 35 | 
| Change from baseline in clinical laboratory test results | Clinical laboratory testing to include Chemistry analytes and Hematology analytes. | Baseline Day -1 to Day 35 | 
| Change from baseline in continuous cardiac monitoring data |  | Baseline Day -1 to Day 35 | 
| Change from baseline in physical examination findings |  | Baseline Day -1 to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1 |  | Day -1 to Day 4 | 
| Largest decrease in HR from time-matched Day -1 baseline |  | Day -1 to Day 4 | 
| Time to nadir HR from time 0 hour (predose) |  | Day -1 to Day 4 | 
| Percent reduction in HR at nadir from time-matched Day -1 HR value |  | Day -1 to Day 4 | 
| Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 HR value |  | Day -1 to Day 7 | 
| Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects |  | Day -1 to Day 4 | 
| Largest decrease in ALC from time-matched Day -1 baseline |  | Day -1 to Day 4 | 
| Time to nadir ALC from time 0 hour (predose) |  | Day -1 to Day 4 | 
| Percent reduction in ALC at nadir from time-matched Day -1 value |  | Day -1 to Day 4 | 
| Mean change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 ALC value |  | Day -1 to Day 7 |