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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-07104091 Sequence 1<br>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)<br>* A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.<br>* Other names: Tablet Formulation A, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)<br>* A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.<br>* Other names: Tablet Formulation B, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.<br>* Other names: Tablet Formulation C, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)<br>* A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.<br>* Other names: Tablet Formulation D, Fasted;|
| Experimental: PF-07104091 Sequence 2<br>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)<br>* A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.<br>* Other names: Tablet Formulation A, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)<br>* A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.<br>* Other names: Tablet Formulation B, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.<br>* Other names: Tablet Formulation C, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)<br>* A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.<br>* Other names: Tablet Formulation D, Fasted;|
| Experimental: PF-07104091 Sequence 3<br>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)<br>* A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.<br>* Other names: Tablet Formulation A, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)<br>* A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.<br>* Other names: Tablet Formulation B, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.<br>* Other names: Tablet Formulation C, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)<br>* A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.<br>* Other names: Tablet Formulation D, Fasted;|
| Experimental: PF-07104091 Sequence 4<br>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)<br>* A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.<br>* Other names: Tablet Formulation A, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)<br>* A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.<br>* Other names: Tablet Formulation B, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.<br>* Other names: Tablet Formulation C, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.<br>* Other names: Tablet Formulation C, Fed;|
| Experimental: PF-07104091 Sequence 5<br>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)<br>* A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.<br>* Other names: Tablet Formulation A, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)<br>* A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.<br>* Other names: Tablet Formulation B, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.<br>* Other names: Tablet Formulation C, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.<br>* Other names: Tablet Formulation C, Fed;|
| Experimental: PF-07104091 Sequence 6<br>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)<br>* A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.<br>* Other names: Tablet Formulation A, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)<br>* A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.<br>* Other names: Tablet Formulation B, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.<br>* Other names: Tablet Formulation C, Fasted;Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)<br>* A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.<br>* Other names: Tablet Formulation C, Fed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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 |  | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of PF-07104091 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of Tablet Formulation C |  | 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) |  | 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 |  | 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 |  | 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 |  | 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 |  | From baseline up to 28 days after final dose of PF-07104091 | 
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings |  | From baseline up to 28 days after final dose of PF-07104091 | 
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs |  | From baseline up to 28 days after final dose of PF-07104091 | 
| Number of Participants With Abnormalities in Physical Examination |  | From baseline up to 28 days after final dose of PF-07104091 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-07104091, Food-effect, Relative Bioavailability, Pharmacokinetics, Cyclin-Dependent Kinase 2 (CDK2) inhibitor