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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
10
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.
Pfizer Clinical Research Unit
Brussels, Be-bru, Belgium
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 20 minutes post dose