A Taste Assessment of BMS-986165 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986165

Drug: Active Pharmaceutical Ingredient

Study type

Interventional

Funder types

Industry

Identifiers

NCT03751228

IM011-068

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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