A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants

November 8, 2022 updated by: Pfizer

A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, 5-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE BIOAVAILABILITY OF PF-07104091

This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
  • Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of >50 kg (110 lb).
  • Written evidence of a personally signed and dated informed consent document (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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • 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 (eg, contact with positive case, residence, or travel to an area with high incidence) 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.
  • A positive urine drug test.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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-07104091 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Names:
  • Tablet Formulation D, Fasted
Experimental: PF-07104091 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Names:
  • Tablet Formulation D, Fasted
Experimental: PF-07104091 Sequence 3
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Names:
  • Tablet Formulation D, Fasted
Experimental: PF-07104091 Sequence 4
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Names:
  • Tablet Formulation C, Fed
Experimental: PF-07104091 Sequence 5
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Names:
  • Tablet Formulation C, Fed
Experimental: PF-07104091 Sequence 6
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Names:
  • Tablet Formulation C, Fed

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-07104091 to estimate relative bioavailability of Tablet Formulations A, B, and C
Time Frame: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 to estimate relative bioavailability of Tablet Formulation A, B, and C
Time Frame: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
0 (pre-dose), 0.5, 0.75, 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-07104091 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of Tablet Formulation C
Time Frame: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: From baseline up to 28 days after final dose of PF-07104091
From baseline up to 28 days after final dose of PF-07104091
Cmax of PF-07104091 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of Tablet Formulation C
Time Frame: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf of PF-07104091 to estimate the bioavailability of Tablet Formulation D
Time Frame: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax if PF-07104091 to estimate the bioavailability of Tablet Formulation D
Time Frame: 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Participants With Laboratory Abnormalities
Time Frame: From baseline up to 28 days after final dose of PF-07104091
From baseline up to 28 days after final dose of PF-07104091
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Time Frame: From baseline up to 28 days after final dose of PF-07104091
From baseline up to 28 days after final dose of PF-07104091
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: From baseline up to 28 days after final dose of PF-07104091
From baseline up to 28 days after final dose of PF-07104091
Number of Participants With Abnormalities in Physical Examination
Time Frame: From baseline up to 28 days after final dose of PF-07104091
From baseline up to 28 days after final dose of PF-07104091

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Actual)

October 17, 2022

Study Completion (Actual)

October 17, 2022

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

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

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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