ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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)
- 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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Descriptive Information | |||||
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Brief Title ICMJE | PF-06651600 Taste Study. | ||||
Official Title ICMJE | A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE | ||||
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 Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Basic Science | ||||
Condition ICMJE | Healthy Participants | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 10 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | May 10, 2019 | ||||
Actual Primary Completion Date | May 10, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03916393 | ||||
Other Study ID Numbers ICMJE | B7981021 2019-000108-13 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |