PF-06651600 Taste Study.

Study Overview
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Brief Summary
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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.

Official Title
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A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: PF-06651600 20 mg
* Other: Bitrex solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06651600 Treatment A<br>Active pharmaceutical ingredient (API)solution in water | Drug: PF-06651600 20 mg<br>* PF-06651600 in four (4) different oral formulations will be administered in different periods.<br>|
| Experimental: PF-06651600 Treatment B<br>API in sweetened solution | Drug: PF-06651600 20 mg<br>* PF-06651600 in four (4) different oral formulations will be administered in different periods.<br>|
| Experimental: PF-06651600 Treatment C<br>API blend suspension in water | Drug: PF-06651600 20 mg<br>* PF-06651600 in four (4) different oral formulations will be administered in different periods.<br>|
| Experimental: PF-06651600 Treatment D<br>API blend suspension in apple sauce | Drug: PF-06651600 20 mg<br>* PF-06651600 in four (4) different oral formulations will be administered in different periods.<br>|
| Other: Bitrex (Registered) Treatment E<br>Positive control for bitterness | Other: Bitrex solution<br>* Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-06651600, Palatability, Bitrex, Taste Study