PF-06651600 Taste Study.
A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE
2 other identifiers
interventional
10
1 country
1
Brief Summary
This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. A group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (PF-06651600 active pharmaceutical ingredient) and Bitrex (Registered) positive control in a specified sequence in 1 day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedStudy Start
First participant enrolled
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedJune 5, 2019
June 1, 2019
25 days
April 12, 2019
June 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Number of subjects reporting overall liking of drug formulation
Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Baseline through 20 minutes post dose
Percentage of subjects reporting overall liking of drug formulation
Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Baseline through 20 minutes post dose
Number of subjects reporting saltiness of drug formulation
Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Percentage of subjects reporting saltiness of drug formulation
Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Number of subjects reporting bitterness of drug formulation
Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Percentage of subjects reporting bitterness of drug formulation
Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Number of subjects reporting mouth feel of drug formulation
Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Percentage of subjects reporting mouth feel of drug formulation
Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Number of subjects reporting sourness of drug formulation
Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Percentage of subjects reporting sourness of drug formulation
Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Number of subjects reporting tongue/mouth burn from drug formulation
Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Percentage of subjects reporting tongue/mouth burn from drug formulation
Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Baseline through 20 minutes post dose
Number of subjects reporting formulation preference
Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Baseline through 20 minutes post dose
Percentage of subjects reporting formulation preference
Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Baseline through 20 minutes post dose
Study Arms (5)
PF-06651600 Treatment A
EXPERIMENTALActive pharmaceutical ingredient (API)solution in water
PF-06651600 Treatment B
EXPERIMENTALAPI in sweetened solution
PF-06651600 Treatment C
EXPERIMENTALAPI blend suspension in water
PF-06651600 Treatment D
EXPERIMENTALAPI blend suspension in apple sauce
Bitrex (Registered) Treatment E
OTHERPositive control for bitterness
Interventions
PF-06651600 in four (4) different oral formulations will be administered in different periods.
Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.
Eligibility Criteria
You may qualify if:
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Infection with Hepatitis B, C or HIV
- Participants with conditions that affect their ability to taste
- Participants who currently smoke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Clinical Research Unit
Brussels, Be-bru, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
April 15, 2019
Primary Completion
May 10, 2019
Study Completion
May 10, 2019
Last Updated
June 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.