Hepatic ImpairmentPhase 1NCT07677358
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease
A Phase 1 study testing Atirmociclib in people with Hepatic Impairment and Healthy, Hepatic Insufficiency, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health. The study is seeking participants who are: Aged 18 years or older Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy Adults
- What is being tested?
- Atirmociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2026to 10 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 17.5-40 kg/m2; and a total body weight >50 kg (110 lb).
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent.
- Normal hepatic function group only:
- Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.
- Hepatic impairment groups only:
- Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.
Who cannot join
- Any condition or history of surgery possibly affecting drug absorption.
- Use of prohibited prior or concomitant medications.
- Normal hepatic function group only:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Hepatic impairment groups only:
- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Floridian Clinical Research
Miami Lakes, Florida, 33016
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
- Recruiting
Genesis Clinical Research
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.
The study is seeking participants who are:
Read more
- Aged 18 years or older
- Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg.
- Have normal liver function or have stable mild, moderate, or severe liver disease
Participants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.
Participants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.
- Being tested
- Atirmociclib
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtirmociclibDrug
Also called PF-07220060
atirmociclib administered as a single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Normal Hepatic Function | Experimental | Atirmociclib administered as a single oral dose Receives: Drug: Atirmociclib |
| Group 4: Severe Hepatic Impairment | Experimental | Atirmociclib administered as a single oral dose Receives: Drug: Atirmociclib |
| Group 3: Moderate Hepatic Impairment | Experimental | Atirmociclib administered as a single oral dose Receives: Drug: Atirmociclib |
| Group 2: Mild Hepatic Impairment | Experimental | Atirmociclib administered as a single oral dose Receives: Drug: Atirmociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with normal hepatic function
Measured: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with hepatic impairment
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with hepatic impairment
Measured: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with normal hepatic function
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with impaired hepatic function
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose
Secondary outcomes (7)
Number of Participants With Treatment-Emergent Adverse Events
Measured: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of atirmociclib
Number of Participants With Normal Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities
Measured: Baseline and Day 2, Day 7 after a single oral dose of atirmociclib
Number of Participants With Impaired Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities
Measured: Baseline and Day 2, Day 9 after a single oral dose of atirmociclib
Number of Participants With Normal Hepatic Function having Clinically Significant Change From Baseline in Vital Signs
Measured: Predose and at 4, 144 hours after a single oral dose of atirmociclib
Number of Participants With Impaired Hepatic function having Clinically Significant Change From Baseline in Vital Signs
Measured: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Number of Participants With Normal Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities
Measured: Predose and at 4, 144 hours after a single oral dose of atirmociclib
Number of Participants With Impaired Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities
Measured: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start29 Jun 2026
- Primary completion14 Aug 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
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
- NCT07677358
- Sponsor's protocol ID
- C4391014
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2026
- 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, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
- ClinicalTrials.gov ID
- NCT07677358
- Acronym / sponsor ID
- C4391014
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 30 Jun 2026 (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 study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.
The study is seeking participants who are:
- Aged 18 years or older
- Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg.
- Have normal liver function or have stable mild, moderate, or severe liver disease
Participants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.
Participants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Normal Hepatic Function | Experimental | Drug: AtirmociclibAtirmociclib administered as a single oral dose |
| Group 4: Severe Hepatic Impairment | Experimental | Drug: AtirmociclibAtirmociclib administered as a single oral dose |
| Group 3: Moderate Hepatic Impairment | Experimental | Drug: AtirmociclibAtirmociclib administered as a single oral dose |
| Group 2: Mild Hepatic Impairment | Experimental | Drug: AtirmociclibAtirmociclib administered as a single oral dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI of 17.5-40 kg/m2; and a total body weight >50 kg (110 lb).
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent.
- Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.
- Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.
Key exclusion criteria (6 listed)
- Any condition or history of surgery possibly affecting drug absorption.
- Use of prohibited prior or concomitant medications.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.
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 |
|---|---|---|
| AtirmociclibAlso: PF-07220060atirmociclib administered as a single oral dose | Drug | Group 1: Normal Hepatic Function, Group 2: Mild Hepatic Impairment, Group 3: Moderate Hepatic Impairment, Group 4: Severe Hepatic Impairment |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function
Time frame: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with normal hepatic function
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with hepatic impairment
Time frame: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with hepatic impairment
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with normal hepatic function
Time frame: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with impaired hepatic function
Time frame: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
7 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of atirmociclib
Number of Participants With Normal Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities
Time frame: Baseline and Day 2, Day 7 after a single oral dose of atirmociclib
Number of Participants With Impaired Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities
Time frame: Baseline and Day 2, Day 9 after a single oral dose of atirmociclib
Number of Participants With Normal Hepatic Function having Clinically Significant Change From Baseline in Vital Signs
Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib
Number of Participants With Impaired Hepatic function having Clinically Significant Change From Baseline in Vital Signs
Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Number of Participants With Normal Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib
Number of Participants With Impaired Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites 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 in people with Hepatic Impairment and Healthy, Hepatic Insufficiency, run by Pfizer at 3 sites 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 7 inclusion and 6 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: looking for participants now, 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 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function (time frame: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose). The study lists 4 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.