A Taste Assessment of BMS-986165 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751228
• Other study ID #: IM011-068
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2018
• Est. completion date: November 26, 2018

Study information

• Verified date: September 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Swish and expectorate after tasting
• Active Pharmaceutical Ingredient
Swish and expectorate after tasting

Locations

Country	Name	City	State
United States	Senopsys	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form