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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: PF-07284890 Treatment A; Drug: PF-07284890 Treatment B; Drug: PF-07284890 Treatment C

• Registration Number: NCT05349864
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Study Start: 2022-06-17
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2023-08
• Results First Submitted: 2023-08-17
• Results First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Results First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-07284890 Sequence 1	PF-07284890 Treatment A	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.
PF-07284890 Sequence 1	PF-07284890 Treatment B	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.
PF-07284890 Sequence 1	PF-07284890 Treatment C	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.
PF-07284890 Sequence 2	PF-07284890 Treatment A	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.
PF-07284890 Sequence 2	PF-07284890 Treatment B	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.
PF-07284890 Sequence 2	PF-07284890 Treatment C	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2	AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2	AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2	Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
AUClast of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
AUCinf of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Cmax of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.

Secondary Outcome Measures

Name	Time	Method
Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	Vz/F was defined as the apparent volume of distribution for extravascular dosing. Determination method of Vz/F was dose/(AUCinf\*kel), where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks	An AE was defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any events occurring following start of treatment were considered as TEAEs.
Number of Participants With Clinical Laboratory Abnormalities	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks	The hematological (Lymphocytes/Leukocytes, Neutrophils/Leukocytes and Monocytes/Leukocytes), clinical chemistry (Urate and Potassium) and urinalysis (Urine Hemoglobin, Leukocyte Esterase and Bacteria) safety tests were assessed against the pre-specified criteria. The assessment did not take into account whether each participant's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter.
Time to Reach Cmax (Tmax) of PF-07284890 in Plasma	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	Tmax was defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence.
Number of Participants With Pre-Specified Categorization Criteria for Vital Signs	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks	Supine systolic/diastolic blood pressure (BP) and pulse rate (PR) were measured and evaluated against pre-specified categorization criteria. The criteria included change of supine systolic/diastolic BP \>=30 mmHg increase or decrease, and value of supine PR \>120 beats per minute (bpm).
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks	Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate (HR) and measured PR interval, QT interval, corrected QT interval using Fridericia's formula (QTcF), and time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) complex. The number of participants with PR/QRS values and percent change from baseline, QT interval values, and QTcF values and increases from baseline in the pre-specified categories were summarized in this outcome measure (OM).
Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	t1/2 was defined as the time required for the plasma concentration to decline by 50% during the elimination phase. t1/2 = loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Apparent Clearance (CL/F) of PF-07284890 in Plasma	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3	CL/F was defined as the apparent clearance. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL/F = dose/AUCinf, where AUCinf was the area under the plasma concentration-time curve from time zero extrapolated to infinity.

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States