Healthy Participants
Conditions
Keywords
PF-06651600, Palatability, Bitrex, Taste Study
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.
Interventions
DRUGPF-06651600 20 mg
PF-06651600 in four (4) different oral formulations will be administered in different periods.
OTHERBitrex solution
Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects reporting overall liking of drug formulation | Baseline through 20 minutes post dose | 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. |
| Percentage of subjects reporting overall liking of drug formulation | Baseline through 20 minutes post dose | 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. |
| Number of subjects reporting saltiness of drug formulation | Baseline through 20 minutes post dose | 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 |
| Percentage of subjects reporting saltiness of drug formulation | Baseline through 20 minutes post dose | 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 |
| Number of subjects reporting bitterness of drug formulation | Baseline through 20 minutes post dose | 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 |
| Percentage of subjects reporting bitterness of drug formulation | Baseline through 20 minutes post dose | 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 |
| Number of subjects reporting mouth feel of drug formulation | Baseline through 20 minutes post dose | 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 |
| Percentage of subjects reporting mouth feel of drug formulation | Baseline through 20 minutes post dose | 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 |
| Number of subjects reporting sourness of drug formulation | Baseline through 20 minutes post dose | 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 |
| Percentage of subjects reporting sourness of drug formulation | Baseline through 20 minutes post dose | 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 |
| Number of subjects reporting tongue/mouth burn from drug formulation | Baseline through 20 minutes post dose | 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 |
| Percentage of subjects reporting tongue/mouth burn from drug formulation | Baseline through 20 minutes post dose | 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 |
| Number of subjects reporting formulation preference | Baseline through 20 minutes post dose | 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. |
| Percentage of subjects reporting formulation preference | Baseline through 20 minutes post dose | 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. |
Countries
Belgium
Outcome results
None listed