A Taste Assessment of BMS-986165 in Healthy Participants

NCT03751228 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-068
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

BMS-986165 taste evaluation

EXPERIMENTAL

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

Drug: BMS-986165; Drug: Active Pharmaceutical Ingredient

Interventions

BMS-986165 DRUG

Swish and expectorate after tasting

BMS-986165 taste evaluation

Active Pharmaceutical Ingredient DRUG

Swish and expectorate after tasting

Also known as: API

BMS-986165 taste evaluation

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Senopsys

Woburn, Massachusetts, 01801, United States

Location

Related Links

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

MeSH Terms

Interventions

deucravacitinib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 23, 2018
• Study Start: October 11, 2018
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

US (1)