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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-07284890 Treatment B; Drug: PF-07284890 Treatment A; Drug: PF-07284890 Treatment C

Study type: Interventional

Funder types: Industry

Identifiers

NCT05349864

C4471002

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

PF-07284890 Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: PF-07284890 Treatment A

Drug: PF-07284890 Treatment B

Drug: PF-07284890 Treatment C

PF-07284890 Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: PF-07284890 Treatment A

Drug: PF-07284890 Treatment B

Drug: PF-07284890 Treatment C