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Completed

NCT Number: NCT03751228

A Taste Assessment of BMS-986165 in Healthy Participants

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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Key information

Conditions

Healthy Participants

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Senopsys

Woburn, Massachusetts, 01801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986165

Drug

Swish and expectorate after tasting

Active Pharmaceutical Ingredient

Drug

Swish and expectorate after tasting

Other names: API

Primary outcomes

  1. Taste properties of BMS-986165 alone & in prototypes to determine Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria

    Time frame: Approximately 2 years

  2. Taste properties of BMS-986165 alone & in prototypes to determine amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria

    Time frame: Approximately 2 years

  3. Taste properties of BMS-986165 alone & in prototypes to determine mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria

    Time frame: Approximately 2 years

  4. Taste properties of BMS-986165 alone & in prototypes to determine off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria

    Time frame: Approximately 2 years

  5. Taste properties of BMS-986165 alone & in prototypes to determine aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria

    Time frame: Approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2018
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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