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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349864
• Other study ID #: C4471002
• Status: Completed
• Phase: Phase 1
• Start date: June 17, 2022
• Est. completion date: September 16, 2022

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-07284890 Treatment A
PF-07284890 tablet by mouth while fasting
• PF-07284890 Treatment B
PF-07284890 tablet after low fat meal
• PF-07284890 Treatment C
PF-07284890 tablet after high fat meal

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Primary	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	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.	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
Primary	Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition	Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.	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
Primary	AUClast of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition	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.	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
Primary	AUCinf of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition	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.	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
Primary	Cmax of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition	Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.	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
Secondary	Time to Reach Cmax (Tmax) of PF-07284890 in Plasma	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.	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
Secondary	Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma	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.	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
Secondary	Apparent Clearance (CL/F) of PF-07284890 in Plasma	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.	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
Secondary	Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma	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.	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
Secondary	Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)	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.	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
Secondary	Number of Participants With Clinical Laboratory Abnormalities	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.	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
Secondary	Number of Participants With Pre-Specified Categorization Criteria for Vital Signs	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).	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
Secondary	Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)	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).	From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks

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