A Taste Assessment of BMS-986165 in Healthy Participants

NCT03751228 — Phase 1, Completed, 9 participants, Bristol-Myers Squibb

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

Registry	NCT03751228
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	9 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Participants
Interventions	BMS-986165, Active Pharmaceutical Ingredient (Drug)
Dates	start 2018-10-11, primary completion 2018-11-26, completion 2018-11-26, first posted 2018-11-23, last updated 2019-10-01
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
BMS-986165 taste evaluation	Experimental	Drug: BMS-986165; Drug: Active Pharmaceutical Ingredient	BMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners

BMS-986165 (Drug): Swish and expectorate after tasting
Active Pharmaceutical Ingredient (Drug), also known as API: Swish and expectorate after tasting

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All, ages: 25 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Senopsys	Woburn, Massachusetts	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

My Notes

Public

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