PF-06651600 Taste Study.

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916393
• Other study ID #: B7981021
• Secondary ID: 2019-000108-13
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2019
• Est. completion date: May 10, 2019

Study information

• Verified date: June 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-06651600 20 mg
PF-06651600 in four (4) different oral formulations will be administered in different periods.

Other:
• Bitrex solution
Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels	Be-bru

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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