A Taste Assessment of BMS-986165 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the taste characteristics of BMS-986165 formulations, alone and mixed, in order to develop a pediatric oral form of BMS-986165.

Official Title
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An Open-Label Taste Assessment of BMS-986165 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Active Pharmaceutical Ingredient


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: WOCBP must agree to follow instructions for method(s) of contraception for 5 half-lives of BMS-986165 (2 days) plus 30 days (duration of ovulatory cycle) for a total of 32 days after each tasting day. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception 5 half-lives of the study drug (2 days) after each tasting day. Exclusion Criteria: A known sensitivity to BMS-986165 A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the participant. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 taste evaluation<br>BMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners | Drug: BMS-986165<br>* Swish and expectorate after tasting<br>Drug: Active Pharmaceutical Ingredient<br>* Swish and expectorate after tasting<br>* Other names: API;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste properties of BMS-986165 alone & in prototypes to determine Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria |  | Approximately 2 years | 
| Taste properties of BMS-986165 alone & in prototypes to determine amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria |  | Approximately 2 years | 
| Taste properties of BMS-986165 alone & in prototypes to determine mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria |  | Approximately 2 years | 
| Taste properties of BMS-986165 alone & in prototypes to determine off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria |  | Approximately 2 years | 
| Taste properties of BMS-986165 alone & in prototypes to determine aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria |  | Approximately 2 years |