A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of subjects reporting overall liking of drug formulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
PF-06651600 Treatment A
Active pharmaceutical ingredient (API)solution in water
干预措施: PF-06651600 20 mg (Drug)
PF-06651600 Treatment B
API in sweetened solution
干预措施: PF-06651600 20 mg (Drug)
PF-06651600 Treatment C
API blend suspension in water
干预措施: PF-06651600 20 mg (Drug)
PF-06651600 Treatment D
API blend suspension in apple sauce
干预措施: PF-06651600 20 mg (Drug)
Bitrex (Registered) Treatment E
Positive control for bitterness
干预措施: Bitrex solution (Other)
结局指标
主要结局
Number of subjects reporting overall liking of drug formulation
时间窗: 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.
Percentage of subjects reporting bitterness of drug formulation
时间窗: 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
Number of subjects reporting mouth feel of drug formulation
时间窗: 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
Percentage of subjects reporting mouth feel of drug formulation
时间窗: 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
Percentage of subjects reporting overall liking of drug formulation
时间窗: 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.
Number of subjects reporting saltiness of drug formulation
时间窗: 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
Percentage of subjects reporting saltiness of drug formulation
时间窗: 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
Number of subjects reporting bitterness of drug formulation
时间窗: 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
Number of subjects reporting sourness of drug formulation
时间窗: 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
Percentage of subjects reporting sourness of drug formulation
时间窗: 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
Number of subjects reporting tongue/mouth burn from drug formulation
时间窗: 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
Percentage of subjects reporting tongue/mouth burn from drug formulation
时间窗: 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
Number of subjects reporting formulation preference
时间窗: 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.
Percentage of subjects reporting formulation preference
时间窗: 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.
次要结局
未报告次要终点