A Taste Assessment of BMS-986165 in Healthy Participants

NCT ID: NCT03751228

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2018-11-26

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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986165 taste evaluation

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

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Swish and expectorate after tasting

Active Pharmaceutical Ingredient

Intervention Type DRUG

Swish and expectorate after tasting

Interventions

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BMS-986165

Swish and expectorate after tasting

Intervention Type DRUG

Active Pharmaceutical Ingredient

Swish and expectorate after tasting

Intervention Type DRUG

Other Intervention Names

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API

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Senopsys

Woburn, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM011-068

Identifier Type: -

Identifier Source: org_study_id

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