The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants. The study is seeking for male and female participants who: * Are 18 years of age or more. * Are confirmed to be healthy after performing some medical and physical tests. * Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more. The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period. Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions. How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants. In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered after low fat meal
A single dose of PF-06821497 administered after high fat meal.
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497
The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
Time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
Maximum Plasma Concentration (Cmax) for PF-06821497.
The Cmax was observed directly from data.
Time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious.
Time frame: From screening up to Day 35
Number of Participants With Laboratory Abnormalities
Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.
Time frame: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.
Number of Participants With Clinically Significant ECG Findings
Single 12-lead electrocardiogram or electrocardiography (ECG) readings were taken at approximately each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.
Time frame: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.
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