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PF-06651600 Taste Study.

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ClinicalTrials.gov Identifier: NCT03916393
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: PF-06651600 20 mg Other: Bitrex solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

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.

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.




Primary Outcome Measures :
  1. Number of subjects reporting overall liking of drug formulation [ Time Frame: 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.

  2. Percentage of subjects reporting overall liking of drug formulation [ Time Frame: 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.

  3. Number of subjects reporting saltiness of drug formulation [ Time Frame: 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

  4. Percentage of subjects reporting saltiness of drug formulation [ Time Frame: 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

  5. Number of subjects reporting bitterness of drug formulation [ Time Frame: 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

  6. Percentage of subjects reporting bitterness of drug formulation [ Time Frame: 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

  7. Number of subjects reporting mouth feel of drug formulation [ Time Frame: 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

  8. Percentage of subjects reporting mouth feel of drug formulation [ Time Frame: 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

  9. Number of subjects reporting sourness of drug formulation [ Time Frame: 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

  10. Percentage of subjects reporting sourness of drug formulation [ Time Frame: 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

  11. Number of subjects reporting tongue/mouth burn from drug formulation [ Time Frame: 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

  12. Percentage of subjects reporting tongue/mouth burn from drug formulation [ Time Frame: 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

  13. Number of subjects reporting formulation preference [ Time Frame: 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.

  14. Percentage of subjects reporting formulation preference [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916393


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Be-bru, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03916393     History of Changes
Other Study ID Numbers: B7981021
2019-000108-13 ( EudraCT Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
PF-06651600
Palatability
Bitrex
Taste Study

Additional relevant MeSH terms:
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Pharmaceutical Solutions
Denatonium
Aversive Agents
Molecular Mechanisms of Pharmacological Action
Abuse-Deterrent Formulations
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents