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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:
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.
Dose proportionality will be evaluated 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Cohort 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | Recruiting | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Phase 1, open-label, randomized, two-period, cross-over study to evaluate the dose proportionality on the pharmacokinetics, safety, and tolerability
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| 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. |
|
| 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. |
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| 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 |