PF-06651600 Taste Study.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Other: Bitrex solution; Drug: PF-06651600 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03916393

2019-000108-13 (EudraCT Number)

B7981021

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 5 patient groups

PF-06651600 Treatment A

Experimental group

Description:

Active pharmaceutical ingredient (API)solution in water

Treatment:

Drug: PF-06651600 20 mg

PF-06651600 Treatment B

Experimental group

Description:

API in sweetened solution

Treatment:

Drug: PF-06651600 20 mg

PF-06651600 Treatment C

Experimental group

Description:

API blend suspension in water

Treatment:

Drug: PF-06651600 20 mg

PF-06651600 Treatment D

Experimental group

Description:

API blend suspension in apple sauce

Treatment:

Drug: PF-06651600 20 mg

Bitrex (Registered) Treatment E

Other group

Description:

Positive control for bitterness

Treatment:

Other: Bitrex solution