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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000108-13 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06651600 Treatment A | Experimental | Active pharmaceutical ingredient (API)solution in water |
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| PF-06651600 Treatment B | Experimental | API in sweetened solution |
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| PF-06651600 Treatment C | Experimental | API blend suspension in water |
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| PF-06651600 Treatment D | Experimental | API blend suspension in apple sauce |
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| Bitrex (Registered) Treatment E | Other | Positive control for bitterness |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 20 mg | Drug | PF-06651600 in four (4) different oral formulations will be administered in different periods. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | Be-bru | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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| Bitrex solution | Other | Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations. |
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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 |