A Study to Compare Two Tablet Formulations of Study Medicine Atirmociclib in Healthy Participants

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participant

Treatments: Drug: PF-07220060

Study type: Interventional

Funder types: Industry

Identifiers

NCT07130097

C4391009

Details and patient eligibility

About

The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market.

The study is seeking participants who are:

• Healthy males and females aged 18 to 65 years
• Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
• Body Mass Index of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (kg) [110 pounds (lb)].

Participants in the study will receive a single dose of PF-07220060 by mouth after a meal, following at least 7 days, the participant will then receive another dose of PF-07220060. Each dose received by the participant will be a different tablet formulation, and the sequence of tablet formulations given will be random (just like a flipside of the coin).

The study will help the team understand how the difference in tablet formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.

Participants will remain in the study clinic for at least 13 days and will have one follow-up contact.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
• Evidence of a personally signed and dated 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:

• 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).
• A positive urine drug test
• Unwilling or unable to comply with the Lifestyle Considerations criteria of this 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Regimen A; Treatment Sequence A

Experimental group

Description:

Single Oral Dose of reference tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of test tablet formulation PF-07220060

Treatment:

Drug: PF-07220060

Regimen B; Treatment Sequence B

Experimental group

Description:

Single Oral Dose of test tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of reference tablet formulation PF-07220060

Treatment:

Drug: PF-07220060