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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2022-09-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PF-07284890 Sequence 1

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.

Group Type EXPERIMENTAL

PF-07284890 Treatment A

Intervention Type DRUG

PF-07284890 tablet by mouth while fasting

PF-07284890 Treatment B

Intervention Type DRUG

PF-07284890 tablet after low fat meal

PF-07284890 Treatment C

Intervention Type DRUG

PF-07284890 tablet after high fat meal

PF-07284890 Sequence 2

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.

Group Type EXPERIMENTAL

PF-07284890 Treatment A

Intervention Type DRUG

PF-07284890 tablet by mouth while fasting

PF-07284890 Treatment B

Intervention Type DRUG

PF-07284890 tablet after low fat meal

PF-07284890 Treatment C

Intervention Type DRUG

PF-07284890 tablet after high fat meal

Interventions

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PF-07284890 Treatment A

PF-07284890 tablet by mouth while fasting

Intervention Type DRUG

PF-07284890 Treatment B

PF-07284890 tablet after low fat meal

Intervention Type DRUG

PF-07284890 Treatment C

PF-07284890 tablet after high fat meal

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes