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

Phase 1

Completed

• Conditions: Healthy
• Interventions: 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)

• Registration Number: NCT05431153
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-09
• Study Start: 2022-06-10
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-24
• Primary Completion: 2022-10-17
• Study Completion: 2022-10-17
• Status Verified: 2023-10
• Results First Submitted: 2023-10-17
• Results First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Results First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-07104091 Sequence 1	Single dose of PF-07104091 as Tablet Formulation A (Treatment A)	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.
PF-07104091 Sequence 1	Single dose of PF-07104091 as Tablet Formulation B (Treatment B)	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.
PF-07104091 Sequence 1	Single dose of PF-07104091 as Tablet Formulation C (Treatment C)	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.
PF-07104091 Sequence 1	Single dose of PF-07104091 as Tablet Formulation D (Treatment D)	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.
PF-07104091 Sequence 2	Single dose of PF-07104091 as Tablet Formulation A (Treatment A)	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.
PF-07104091 Sequence 2	Single dose of PF-07104091 as Tablet Formulation B (Treatment B)	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.
PF-07104091 Sequence 2	Single dose of PF-07104091 as Tablet Formulation C (Treatment C)	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.
PF-07104091 Sequence 2	Single dose of PF-07104091 as Tablet Formulation D (Treatment D)	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.
PF-07104091 Sequence 3	Single dose of PF-07104091 as Tablet Formulation A (Treatment A)	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.
PF-07104091 Sequence 3	Single dose of PF-07104091 as Tablet Formulation B (Treatment B)	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.
PF-07104091 Sequence 3	Single dose of PF-07104091 as Tablet Formulation C (Treatment C)	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.
PF-07104091 Sequence 3	Single dose of PF-07104091 as Tablet Formulation D (Treatment D)	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.
PF-07104091 Sequence 4	Single dose of PF-07104091 as Tablet Formulation A (Treatment A)	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.
PF-07104091 Sequence 4	Single dose of PF-07104091 as Tablet Formulation B (Treatment B)	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.
PF-07104091 Sequence 4	Single dose of PF-07104091 as Tablet Formulation C (Treatment C)	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.
PF-07104091 Sequence 4	Single dose of PF-07104091 as Tablet Formulation C (Treatment E)	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.
PF-07104091 Sequence 5	Single dose of PF-07104091 as Tablet Formulation A (Treatment A)	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.
PF-07104091 Sequence 5	Single dose of PF-07104091 as Tablet Formulation B (Treatment B)	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.
PF-07104091 Sequence 5	Single dose of PF-07104091 as Tablet Formulation C (Treatment C)	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.
PF-07104091 Sequence 6	Single dose of PF-07104091 as Tablet Formulation C (Treatment C)	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.
PF-07104091 Sequence 5	Single dose of PF-07104091 as Tablet Formulation C (Treatment E)	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.
PF-07104091 Sequence 6	Single dose of PF-07104091 as Tablet Formulation A (Treatment A)	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.
PF-07104091 Sequence 6	Single dose of PF-07104091 as Tablet Formulation B (Treatment B)	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.
PF-07104091 Sequence 6	Single dose of PF-07104091 as Tablet Formulation C (Treatment E)	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C	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.
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C	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.

Secondary Outcome Measures

Name	Time	Method
AUCinf of PF-07104091 for Treatment C, D and E	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.
Cmax of PF-07104091 for Treatment C, D and E	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	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.
Number of Participants With Laboratory Test Abnormalities	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.
Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments	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.
Number of Participants With Clinically Meaningful Findings in Vital Signs	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.
Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments	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.

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States