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Liver health may change how a promising cancer drug works in the body

NCT ID NCT07677358

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study investigates how the experimental cancer drug atirmociclib is processed by the body in people with mild, moderate, or severe liver disease compared to those with healthy livers. Participants receive a single oral dose of the drug, and blood samples are taken over time to measure drug levels. The goal is to see if liver impairment alters how the drug behaves, which could guide safer dosing for patients with liver issues. The study involves about 28 adults and lasts roughly 9 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atirmociclib
What this could lead to
If successful, this study could help doctors determine the right dose of atirmociclib for patients with liver problems, making the drug safer to use.
What could go wrong
This is an early-phase study with only 28 participants, so results may not apply to everyone. The drug may still cause side effects regardless of liver function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria including but not limited to: * 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. Exclusion criteria including but not limited to: * 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.

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Conditions

The condition(s) this trial relates to.

Hepatic Insufficiency liver disorder liver failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy adults Healthy, hepatic insufficiency Hepatic impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Floridian Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Genesis Clinical Research

    RECRUITING

    Tampa, Florida, 33603, United States

  • Orlando Clinical Research Center

    RECRUITING

    Orlando, Florida, 32809, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.