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

NCT05767905 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C2321005NCT05767905
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

PF-06821497; Relative Bioavailability; Food Effect

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497

  The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration

  Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.

• Maximum Plasma Concentration (Cmax) for PF-06821497.

  The Cmax was observed directly from data.

  Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.

Secondary Outcomes (3)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs).

  From screening up to Day 35

• Number of Participants With Laboratory Abnormalities

  From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.

• Number of Participants With Clinically Significant ECG Findings

  From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.

Study Arms (3)

Part 1: PF-06821497 Sequence 1

EXPERIMENTAL

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; Drug: PF-06821497 Treatment B; Drug: PF-06821497 Treatment C

Part 1: PF-06821497 Sequence 2

EXPERIMENTAL

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; Drug: PF-06821497 Treatment B; Drug: PF-06821497 Treatment C

Part 2: PF-06821497 Sequence 1

EXPERIMENTAL

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; Drug: PF-06821497 Treatment E; Drug: PF-06821497 Treatment F

Interventions

PF-06821497 Treatment A DRUG

A single dose of PF-06821497 administered under fasting conditions.

Part 1: PF-06821497 Sequence 1; Part 1: PF-06821497 Sequence 2

PF-06821497 Treatment B DRUG

A single dose of PF-06821497 administered under fasting conditions.

Part 1: PF-06821497 Sequence 1; Part 1: PF-06821497 Sequence 2

PF-06821497 Treatment C DRUG

A single dose of PF-06821497 administered under fasting conditions.

Part 1: PF-06821497 Sequence 1; Part 1: PF-06821497 Sequence 2

PF-06821497 Treatment D DRUG

A single dose of PF-06821497 administered under fasting conditions.

Part 2: PF-06821497 Sequence 1

PF-06821497 Treatment E DRUG

A single dose of PF-06821497 administered after low fat meal

Part 2: PF-06821497 Sequence 1

PF-06821497 Treatment F DRUG

A single dose of PF-06821497 administered after high fat meal.

Part 2: PF-06821497 Sequence 1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

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
• Masking Details: Open-label Study
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: March 17, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)