A Taste Assessment of BMS-986165 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986165; Drug: Active Pharmaceutical Ingredient

• Registration Number: NCT03751228
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Primary Completion: 2018-11-26
• Study Completion: 2018-11-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165 taste evaluation	BMS-986165	BMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners
BMS-986165 taste evaluation	Active Pharmaceutical Ingredient	BMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Senopsys; 🇺🇸 Woburn, Massachusetts, United States