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
Completed
Conditions
Intervention / Treatment
- Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
- Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
- Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
- Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
- Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
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
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-
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
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 |
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:
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Names:
|
|
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:
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Names:
|
|
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:
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Names:
|
|
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:
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Names:
|
|
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:
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Names:
|
|
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:
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Names:
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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.
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From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
|
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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.
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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
Investigators
- 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.
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)
April 8, 2024
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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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