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

NCT07215078 | Recruiting Phase 1 FDA Drug

• 1 other identifier: C4391030
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.with BMI of 17.5-30.5 kg/m2; and a total body weight \>50 kgs (110 lbs.).

Conditions

Healthy Volunteer

Keywords

Dose proportionality on the pharmacokinetics; Dose proportionality on the safety and tolerability; Atirmociclib (PF-07220060)

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

  Dose-normalized plasma AUCinf and Cmax of atirmociclib for each cohort (AUClast if AUCinf cannot be estimated)

  1 hour prior to atirmociclib dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose

• Maximum Observed Plasma Concentration (Cmax)

  1 hour prior to atirmociclib dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose

Secondary Outcomes (5)

• Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment

  Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35

• Number of Participants With Laboratory Abnormalities

  Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35

• Number of Participants With Abnormalities in Physical Examination

  Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35

• Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

  Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35

• Number of Participants With Concomitant Medications

  Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35

Study Arms (6)

Cohort 1

EXPERIMENTAL

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.

Drug: atirmociclib (PF-07220060)

Cohort 2

EXPERIMENTAL

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.

Drug: atirmociclib (PF-07220060)

Cohort 3

EXPERIMENTAL

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.

Drug: atirmociclib (PF-07220060)

Cohort 4

EXPERIMENTAL

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.

Drug: atirmociclib (PF-07220060)

Cohort 5

EXPERIMENTAL

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.

Drug: atirmociclib (PF-07220060)

Cohort 6

EXPERIMENTAL

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.

Drug: atirmociclib (PF-07220060)

Interventions

atirmociclib (PF-07220060) DRUG

Open-label, two-period, cross-over study to evaluate dose proportionality of atirmociclib (PF-07220060) pharmacokinetics when administered under fed condition to healthy participants

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1, open-label, randomized, two-period, cross-over study to evaluate the dose proportionality on the pharmacokinetics, safety, and tolerability

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 10, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)