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

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 Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PF-06651600 20 mg; Other: Bitrex solution

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Be-bru
    • Brussels, Be-bru, Belgium, B-1070
      • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Palatability; PF-06651600; Bitrex; Taste Study
• Other Study ID Numbers: B7981021; 2019-000108-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No