A Study to Compare Two Tablet Formulations of Study Medicine Atirmociclib in Healthy Participants
- Registration Number
- NCT07130097
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regimen A; Treatment Sequence A PF-07220060 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 Regimen B; Treatment Sequence B PF-07220060 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
- Primary Outcome Measures
Name Time Method Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf) Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2 AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (If data does not permit reporting of AUCinf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Area under the Plasma Concentration-Time profile (AUC) from time 0 extrapolated to extrapolated infinite time (AUCinf) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data permits). Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2 AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits). It is obtained from AUC (0-t) plus AUC (t-inf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Maximum Observed Plasma Concentration (Cmax) profile of test and reference atirmociclib formulations after a high fat/high calorie meal Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2 Cmax was the maximum observed plasma concentration directly observed from data. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
- Secondary Outcome Measures
Name Time Method Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) Number of Participants with Treatment Emergent Adverse Events (TEAEs) From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) Number of Participants with Clinically Significant Abnormalities in Vital Signs From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)