PF-06651600 Taste Study.

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: PF-06651600 20 mg; Other: Bitrex solution

• Registration Number: NCT03916393
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study Start: 2019-04-15
• Study First Posted: 2019-04-16
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-10
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-06651600 Treatment B	PF-06651600 20 mg	API in sweetened solution
PF-06651600 Treatment C	PF-06651600 20 mg	API blend suspension in water
PF-06651600 Treatment A	PF-06651600 20 mg	Active pharmaceutical ingredient (API)solution in water
Bitrex (Registered) Treatment E	Bitrex solution	Positive control for bitterness
PF-06651600 Treatment D	PF-06651600 20 mg	API blend suspension in apple sauce

Primary Outcome Measures

Name	Time	Method
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 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
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
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.

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Be-bru, Belgium