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
Overview
- Phase
- Phase 1
- Intervention
- PF-07284890 Treatment A
- Conditions
- Healthy Participants
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
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.
Intervention: PF-07284890 Treatment A
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.
Intervention: PF-07284890 Treatment B
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.
Intervention: PF-07284890 Treatment C
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.
Intervention: PF-07284890 Treatment A
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.
Intervention: PF-07284890 Treatment B
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.
Intervention: PF-07284890 Treatment C
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)
- Number of Participants With Clinical Laboratory Abnormalities(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)(From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks)
- 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)
- 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)