Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants
- Conditions
- Healthy Volunteer
- Interventions
- Drug: atirmociclib (PF-07220060)
- Registration Number
- NCT07215078
- Lead Sponsor
- Pfizer
- 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. 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.
We will evaluate the dose proportionality 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 atirmociclib (PF-07220060) 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. Cohort 2 atirmociclib (PF-07220060) 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. Cohort 3 atirmociclib (PF-07220060) 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. Cohort 4 atirmociclib (PF-07220060) 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. Cohort 5 atirmociclib (PF-07220060) 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. Cohort 6 atirmociclib (PF-07220060) 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.
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) 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 Dose-normalized plasma AUCinf and Cmax of atirmociclib for each cohort (AUClast if AUCinf cannot be estimated)
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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit - New Haven
🇺🇸New Haven, Connecticut, United States
Pfizer Clinical Research Unit - New Haven🇺🇸New Haven, Connecticut, United States