Status:
RECRUITING
Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 26 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07215078
Start Date
October 8 2025
End Date
June 26 2026
Last Update
November 28 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States, 06511