Clinical trial NCT03916393: PF-06651600 Taste Study.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: PF-06651600
Palatability
Bitrex
Taste Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Number of subjects reporting overall liking of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting overall liking of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Number of subjects reporting saltiness of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting saltiness of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Number of subjects reporting bitterness of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting bitterness of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Number of subjects reporting mouth feel of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting mouth feel of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Number of subjects reporting sourness of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting sourness of drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Number of subjects reporting tongue/mouth burn from drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting tongue/mouth burn from drug formulation
timeFrame: Baseline through 20 minutes post dose
measure: Number of subjects reporting formulation preference
timeFrame: Baseline through 20 minutes post dose
measure: Percentage of subjects reporting formulation preference
timeFrame: Baseline through 20 minutes post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
state: Be-bru
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: