Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: atirmociclib (PF-07220060)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07215078

C4391030

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the dose proportionality on the PK of the study medicine (called atirmociclib) when administered in the various doses range under the fed condition in healthy participants.

This study is seeking participants who are:

1. male and female aged 18 to 65 years are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
2. with BMI of 17.5-30.5 kg/m2; and a total body weight >50 kgs (110 lbs.).

All participants (72 total) in this study will receive atirmociclib at Dose (A), Dose (B), Dose (C), and Dose (D) oral dose in 1 of the 12 treatment sequences among 6 cohorts under fed conditions.

Atirmociclib will be given by mouth at the study research unit once single dose about 30 minutes after a moderate fat standard calorie meal.

Dose proportionality will be evaluated on the pharmacokinetics (PK), safety and tolerability of atirmociclib at Doses (A), (B), (C), and (D) oral dose under the fed condition.

Including the 28 days of screening window and the 35 days safety follow-up period, the total study duration for each participant can be up to 71 days, containing 2 periods (6 days for each period), minimum 7-day interval between two periods, and follow-up period 28 to 35 days from administration of the final dose of study intervention. During this time, they will undergo safety laboratory and serial blood PK samplings up to 120 hours after administration of atirmociclib to determine plasma concentrations of atirmociclib. Participants will be discharged from the research unit on Period 2 Day 6 following completion of all assessments.

Enrollment: 72 estimated 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.
• Body mass Index (BMI) of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb.).

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).
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
• Concomitant use of any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 are prohibited within 5 half-lives plus 14 days (up to 28 days) prior to first dose of atirmociclib.
• Previous exposure to atirmociclib or participation in studies requiring atirmociclib administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 6 patient groups

Cohort 1

Experimental group

Description:

In Period 1 Day 1, participants from Sequence AB and BA will receive Dose A and Dose B atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Treatment:

Drug: atirmociclib (PF-07220060)

Cohort 2

Experimental group

Description:

In Period 1 Day 1, participants from Sequence AC and CA will receive Dose A and Dose C atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Treatment:

Drug: atirmociclib (PF-07220060)

Cohort 3

Experimental group

Description:

In Period 1 Day 1, participants from Sequence BC and CB will receive Dose B and Dose C atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Treatment:

Drug: atirmociclib (PF-07220060)

Cohort 4

Experimental group

Description:

In Period 1 Day 1, participants from Sequence AD and DA will receive Dose A and Dose D atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Treatment:

Drug: atirmociclib (PF-07220060)

Cohort 5

Experimental group

Description:

In Period 1 Day 1, participants from Sequence BD and DB will receive Dose B and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Treatment:

Drug: atirmociclib (PF-07220060)

Cohort 6

Experimental group

Description:

In Period 1 Day 1, participants from Sequence CD and DC will receive Dose C and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Treatment:

Drug: atirmociclib (PF-07220060)