A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.

A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497

The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants.

The study is seeking for male and female participants who:

• Are 18 years of age or more.
• Are confirmed to be healthy after performing some medical and physical tests.
• Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more.

The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period.

Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions.

How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants.

In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06821497 Treatment A; Drug: PF-06821497 Treatment B; Drug: PF-06821497 Treatment C; Drug: PF-06821497 Treatment D; Drug: PF-06821497 Treatment E; Drug: PF-06821497 Treatment F

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants ≥18 years of age, inclusive, at screening.
• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
• BMI of ≥17.5 kg/m2; and a total body weight >50 kg (110 lb)
• Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

• Evidence or history of clinically significant 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) or prior allergic reaction to any component of PF-06821497.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• 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)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: PF-06821497 Sequence 1; Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: Drug: Single dose of PF-06821497 Treatment A; Drug: Single dose of PF-06821497 Treatment B; Drug: Single dose of PF-06821497 Treatment C	Drug: PF-06821497 Treatment A; A single dose of PF-06821497 administered under fasting conditions.; Drug: PF-06821497 Treatment B; A single dose of PF-06821497 administered under fasting conditions.; Drug: PF-06821497 Treatment C; A single dose of PF-06821497 administered under fasting conditions.
Experimental: Part 1: PF-06821497 Sequence 2; Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: Drug: Single dose of PF-06821497 Treatment A; Drug: Single dose of PF-06821497 Treatment B; Drug: Single dose of PF-06821497 Treatment C	Drug: PF-06821497 Treatment A; A single dose of PF-06821497 administered under fasting conditions.; Drug: PF-06821497 Treatment B; A single dose of PF-06821497 administered under fasting conditions.; Drug: PF-06821497 Treatment C; A single dose of PF-06821497 administered under fasting conditions.
Experimental: Part 2: PF-06821497 Sequence 1; Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: Drug: Single dose of PF-06821497 Treatment D; Drug: Single dose of PF-06821497 Treatment E; Drug: Single dose of PF-06821497 Treatment F	Drug: PF-06821497 Treatment D; A single dose of PF-06821497 administered under fasting conditions.; Drug: PF-06821497 Treatment E; A single dose of PF-06821497 administered after low fat meal; Drug: PF-06821497 Treatment F; A single dose of PF-06821497 administered after high fat meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of PF-06821497 to estimate relative bioavailability for Treatments A and B	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-06821497 to estimate relative bioavailability for Treatments A and B	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf of PF-06821497 for Treatment C relative to Treatments B and A	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-06821497 for Treatment C relative to Treatments B and A	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf of PF-06821497, comparison of low fat meal with fasted	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf of PF-06821497, comparison of high fat meal with fasted	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf of PF-06821497 Treatment D - Fasted	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf of PF-06821497 Treatment E - low fat meal	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf of PF-06821497 Treatment F - high fat meal	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-06821497, comparison of low fat meal with fasted	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-06821497, comparison of high fat meal with fasted	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-06821497 Treatment D - Fasted	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-06821497 Treatment E - low fat meal	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-06821497 Treatment F - high fat meal	0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Participants With Laboratory Abnormalities	From baseline up to 35 days after final dose of PF-06821497
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings	From baseline up to 35 days after final dose of PF-06821497
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	From baseline up to 35 days after final dose of PF-06821497
Number of Participants With Abnormalities in Physical Examination	From baseline up to 35 days after final dose of PF-06821497

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Relative Bioavailability; Food Effect; PF-06821497
• Other Study ID Numbers: C2321005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No