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

NCT05349864 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C4471002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Food effect study

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• 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

• 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

• 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

Study Arms (2)

PF-07284890 Sequence 1

EXPERIMENTAL

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.

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

PF-07284890 Sequence 2

EXPERIMENTAL

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.

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

Interventions

PF-07284890 Treatment A DRUG

PF-07284890 tablet by mouth while fasting

PF-07284890 Sequence 1; PF-07284890 Sequence 2

PF-07284890 Treatment B DRUG

PF-07284890 tablet after low fat meal

PF-07284890 Sequence 1; PF-07284890 Sequence 2

PF-07284890 Treatment C DRUG

PF-07284890 tablet after high fat meal

PF-07284890 Sequence 1; PF-07284890 Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 27, 2022
• Study Start: June 17, 2022
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)