Do blood levels of atirmociclib rise in proportion to higher doses in healthy adults?
A PHASE 1, OPEN-LABEL, TWO-PERIOD, CROSS-OVER STUDY TO EVALUATE DOSE PROPORTIONALITY OF ATIRMOCICLIB (PF-07220060) PHARMACOKINETICS WHEN ADMINISTERED UNDER FED CONDITIONS TO HEALTHY PARTICIPANTS
This trial will test whether increasing oral doses of atirmociclib produce proportionally higher drug levels in the blood of healthy adults aged 18–65.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07215078 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-dose study enrolls 72 healthy volunteers who will each receive four different oral doses of atirmociclib under fed conditions in one of 12 treatment sequences across six cohorts. Dosing occurs about 30 minutes after a moderate-fat, standard calorie meal, and investigators will measure pharmacokinetics, safety, and tolerability after each dose. The main goal is to determine whether exposure (blood levels) increases proportionally as dose increases, and to collect safety data in a controlled research unit setting. Results will inform dosing expectations for future clinical development.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18–65 with BMI 17.5–30.5 kg/m2, body weight over 50 kg, no significant medical conditions, and not taking strong CYP3A4 or UGT2B7 modulators.
Not a fit: People with significant medical illnesses, positive tests for HIV or hepatitis, prior surgeries affecting absorption, or use of interacting medications are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could help define safe and predictable dosing by showing how blood exposure changes with dose, guiding future studies and dosing choices.
How similar studies have performed: Dose-proportionality pharmacokinetic studies are a common and proven step in drug development, although published data specific to atirmociclib are limited.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
New Haven, Connecticut
- Pfizer Clinical Research Unit - New Haven — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.