- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05349864
A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- New Haven Clinical Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
PF-07284890 tablet by mouth while fasting
PF-07284890 tablet after low fat meal
PF-07284890 tablet after high fat meal
|
Experimental: 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. |
PF-07284890 tablet by mouth while fasting
PF-07284890 tablet after low fat meal
PF-07284890 tablet after high fat meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
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
|
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
Time Frame: 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.
|
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
|
Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition
Time Frame: 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.
|
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 of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition
Time Frame: 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.
|
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 of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition
Time Frame: 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.
|
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 of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Reach Cmax (Tmax) of PF-07284890 in Plasma
Time Frame: 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.
|
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
|
Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma
Time Frame: 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.
|
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
|
Apparent Clearance (CL/F) of PF-07284890 in Plasma
Time Frame: 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.
|
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
|
Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma
Time Frame: 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.
|
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
|
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 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.
|
From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
|
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: 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.
|
From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
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Number of Participants With Pre-Specified Categorization Criteria for Vital Signs
Time Frame: 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).
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From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Time Frame: 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).
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From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C4471002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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