Taste Properties of HIV Inhibitor
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-955176
Sponsored by
About this trial
This is an interventional other trial for HIV Infections
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Men and women of non-childbearing potential professional sensory panelists
- Aged between 25 and 80 years
Exclusion Criteria:
- History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness
- Positive HIV test
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS-955176
Arm Description
BMS-955176 specified dose on specified days
Outcomes
Primary Outcome Measures
Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT02608918
First Posted
November 17, 2015
Last Updated
April 13, 2018
Sponsor
ViiV Healthcare
Collaborators
Senopsys, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02608918
Brief Title
Taste Properties of HIV Inhibitor
Official Title
An Open-Label Taste Assessment of BMS-955176 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
May 24, 2016 (Actual)
Study Completion Date
May 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
Senopsys, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the taste properties of HIV inhibitor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-955176
Arm Type
Experimental
Arm Description
BMS-955176 specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-955176
Other Intervention Name(s)
HIV Maturation Inhibitor
Primary Outcome Measure Information:
Title
Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Men and women of non-childbearing potential professional sensory panelists
Aged between 25 and 80 years
Exclusion Criteria:
History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness
Positive HIV test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viiv Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Taste Properties of HIV Inhibitor
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