Healthy VolunteerPhase 1NCT07215078
Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants
A Phase 1 study testing atirmociclib (PF-07220060) in people with Healthy Volunteer, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- atirmociclib (PF-07220060)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to 13 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: 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
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:
Read more
- male and female aged 18 to 65 years are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
- 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.
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.
- Conditions
- Healthy Volunteer
- Being tested
- atirmociclib (PF-07220060)
- Keywords
- Dose proportionality on the pharmacokinetics, Dose proportionality on the safety and tolerability, Atirmociclib (PF-07220060)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: atirmociclib (PF-07220060) |
| 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. Receives: Drug: atirmociclib (PF-07220060) |
| 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. Receives: Drug: atirmociclib (PF-07220060) |
| 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. Receives: Drug: atirmociclib (PF-07220060) |
| 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. Receives: Drug: atirmociclib (PF-07220060) |
| Cohort 5 | 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. Receives: Drug: atirmociclib (PF-07220060) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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 outcomes (5)
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment
Measured: Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35
Number of Participants With Laboratory Abnormalities
Measured: 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
Measured: 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
Measured: Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35
Number of Participants With Concomitant Medications
Measured: Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start8 Oct 2025
- Primary completion21 Jul 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Phase 1, open-label, randomized, two-period, cross-over study to evaluate the dose proportionality on the pharmacokinetics, safety, and tolerability
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215078
- Sponsor's protocol ID
- C4391030
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07215078
- Acronym / sponsor ID
- C4391030
- Conditions
- Healthy Volunteer
- Keywords
- Dose proportionality on the pharmacokinetics, Dose proportionality on the safety and tolerability, Atirmociclib (PF-07220060)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- male and female aged 18 to 65 years are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Phase 1, open-label, randomized, two-period, cross-over study to evaluate the dose proportionality on the pharmacokinetics, safety, and tolerability
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 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 6 | Experimental | Drug: 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. |
| Cohort 2 | Experimental | Drug: 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 4 | Experimental | Drug: 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 3 | Experimental | Drug: 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 5 | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atirmociclib (PF-07220060)Open-label, two-period, cross-over study to evaluate dose proportionality of atirmociclib (PF-07220060) pharmacokinetics when administered under fed condition to healthy participants | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: 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)
Time frame: 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
5 secondary outcomes
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment
Time frame: Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35
Number of Participants With Laboratory Abnormalities
Time frame: 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
Time frame: 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
Time frame: Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35
Number of Participants With Concomitant Medications
Time frame: Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing atirmociclib (PF-07220060) in people with Healthy Volunteer, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.