A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of a low-fat and high-fat meal on the medicine called PF-07284890 following three single doses PF-07284890. The study will include male participants and female participants of non-childbearing potential who are healthy. Participants will be required to stay in the clinical research unit for 15 days and 14 nights.

Official Title
-----------------
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, 2-SEQUENCE, 3 PERIOD CROSSOVER STUDY TO EVALUATE THE EFFECT OF A LOW-FAT AND HIGH-FAT MEAL ON THE RELATIVE BIOAVAILABILITY OF PF-07284890 IN HEALTHY ADULT PARTICIPANTS

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: PF-07284890 Treatment A
* Drug: PF-07284890 Treatment B
* Drug: PF-07284890 Treatment C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females of non-childbearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. 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 uveitis, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), including any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-07284890 Sequence 1<br>PF-07284890 tablet will be taken by mouth in a single dose for Treatment A while fasting. Five days later PF-07284890 tablet will be taken by mouth for Treatment B after a low fat meal. Five days later PF-07284890 tablet will be taken by mouth for Treatment C after a high fat meal. | Drug: PF-07284890 Treatment A<br>* PF-07284890 tablet by mouth while fasting<br>Drug: PF-07284890 Treatment B<br>* PF-07284890 tablet after low fat meal<br>Drug: PF-07284890 Treatment C<br>* PF-07284890 tablet after high fat meal<br>|
| Experimental: PF-07284890 Sequence 2<br>PF-07284890 tablet will be taken by mouth for Treatment B after a low fat meal. Five days later PF-07284890 tablet will be taken by mouth in a single dose for Treatment A while fasting. Five days later PF-07284890 tablet will be taken by mouth for Treatment C after a high fat meal. | Drug: PF-07284890 Treatment A<br>* PF-07284890 tablet by mouth while fasting<br>Drug: PF-07284890 Treatment B<br>* PF-07284890 tablet after low fat meal<br>Drug: PF-07284890 Treatment C<br>* PF-07284890 tablet after high fat meal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07284890, comparison of low fat meal with fasted state |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUClast of PF-07284890, comparison of high fat meal with fasted state |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUClast of PF-07284890 Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUClast of PF-07284890 Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUClast of PF-07284890 Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07284890, comparison of low fat meal with fasted state |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUCinf of PF-07284890, comparison of high fat meal with fasted state |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUCinf of PF-07284890 Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUCinf of PF-07284890 Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| AUCinf of PF-07284890 Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Maximum Observed Plasma Concentration (Cmax) of PF-07284890, comparison of low fat meal with fasted state |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of PF-07284890, comparison of high-fat meal with fasted state |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of PF-07284890Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of PF-07284890 Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of PF-07284890 Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07284890 in Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Tmax of PF-07284890 in Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Tmax of PF-07284890 in Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Plasma Decay Half-Life (t1/2) of PF-07284890 in Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| t1/2 of PF-07284890 in Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| t1/2 of PF-07284890 in Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Apparent Oral Clearance (CL/F) of PF-07284890 in Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| CL/F of PF-07284890 in Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| CL/F of PF-07284890 in Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Apparent Volume of Distribution (Vz/F) of PF-07284890 in Treatment A - Fasted |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Vz/F of PF-07284890 in Treatment B - low fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Vz/F of PF-07284890 in Treatment C - high fat meal |  | 0, 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) |  | Baseline up to 35 days after last dose | 
| Number of Participants With Laboratory Abnormalities |  | Baseline and Day 2 for each of the treatments | 
| Number of Participants With Vital Signs Abnormalities |  | Baseline through Day 4 for each of the treatments | 
| Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters |  | Baseline, Day 1, and Day 4 for each of the treatments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food effect study