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

October 17, 2023 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
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.
Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
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.
Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
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.
Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
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.
Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
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.
Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Names:
  • Tablet Formulation A, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
  • Tablet Formulation B, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
  • Tablet Formulation C, Fasted
Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Predose, 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 for Treatment A, B and C
Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax was maximum observed concentration. Cmax was observed directly from data.
Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUCinf of PF-07104091 for Treatment C, D and E
Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-07104091 for Treatment C, D and E
Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax was maximum observed concentration. Cmax was observed directly from data.
Predose, 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 (TEAEs) and Serious TEAEs
Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, other important medical events. TEAEs were defined as events that occurred after start of treatment.
From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Laboratory Test Abnormalities
Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry parameters included: blood urea nitrogen and creatinine, cystatin C and estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, urinalysis parameters included: local dipstick: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrites, leukocyte esterase. Number of participants with abnormal findings are presented in this outcome measure.
From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments
Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment.
From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Clinically Meaningful Findings in Vital Signs
Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Vital signs were measured with the participant's arm supported at the level of the heart after approximately 5 minutes of rest. Vital signs parameters included: diastolic and systolic blood pressure, respiratory rate, pulse rate, and temperature. Number of participants with clinically meaningful findings in any vital sign parameter were reported. Clinically meaningful findings were based on the investigator's judgment.
From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments
Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
A complete physical examination included at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinically significant findings were defined according to investigator's assessment.
From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C4161007

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

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