Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to establish if BMS-986165 is safe and effective at treating autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for inhibiting autoimmune conditions. This study will be the first time this drug is given to humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A will investigate single oral doses of drug. Part B will investigate giving the drug daily for 14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule makes a difference to the safety and potential use of this drug.

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986165 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986165 in Subjects With Moderate to Severe Psoriasis

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Interferon alpha-2a recombinant
* Drug: Famotidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy Male and Female participants 18 to 50 years of age (Parts A-D) Exclusion Criteria: Participants that had recent infections Participants with low blood pressure or increased heart rate Participants with any chronic health related problems Participants with active cancer within the last 5 years Participants with any other major medical illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Single ascending dose<br>BMS-986165 or Placebo specified dose on specified days | Drug: BMS-986165<br> <br> Other: Placebo<br> <br> |
| Experimental: Part B: Multiple ascending dose<br>BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days | Drug: BMS-986165<br> <br> Drug: Interferon alpha-2a recombinant<br> <br> Other: Placebo<br> <br> |
| Experimental: Part C: Multiple ascending dose<br>BMS-986165 or Placebo specified dose on specified days | Drug: BMS-986165<br> <br> Other: Placebo<br> <br> |
| Experimental: Part D: Relative Bioavailability<br>BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days | Drug: BMS-986165<br> <br> Drug: Famotidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations | Adverse Event (AE), Serious adverse event (SAE) | Approximately 3 months | 
| Tolerability of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations |  | Approximately 3 months | 
| Safety of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations |  | Approximately 3 months | 
| Tolerability of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations |  | Approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of BMS-986165 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D) |  | Approximately 3 months | 
| Effect of BMS-986165 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D) |  | Approximately 3 months | 
| Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D) |  | Approximately 3 months | 
| Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D) |  | Approximately 3 months |