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Completed

NCT Number: NCT03916393

PF-06651600 Taste Study.

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, Be-bru, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-06651600 20 mg

Drug

PF-06651600 in four (4) different oral formulations will be administered in different periods.

Bitrex solution

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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