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A Taste Assessment of BMS-986165 in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03751228
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
1.5
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Taste Assessment of BMS-986165 in Healthy Participants
Actual Study Start Date :
Oct 11, 2018
Actual Primary Completion Date :
Nov 26, 2018
Actual Study Completion Date :
Nov 26, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986165 taste evaluation

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

Drug: BMS-986165
Swish and expectorate after tasting

Drug: Active Pharmaceutical Ingredient
Swish and expectorate after tasting
Other Names:
  • API

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [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 [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 [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 [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 [Approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Senopsys Woburn Massachusetts United States 01801

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03751228
    Other Study ID Numbers:
    • IM011-068
    First Posted:
    Nov 23, 2018
    Last Update Posted:
    Oct 1, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    BMS-986165

    Study Results

    No Results Posted as of Oct 1, 2019