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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

24. juni 2026 opdateret af: Pfizer

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:

  • 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

28

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Floridian Clinical Research
      • Orlando, Florida, Forenede Stater, 32809
        • Orlando Clinical Research Center
      • Tampa, Florida, Forenede Stater, 33603
        • Genesis Clinical Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Normal Hepatic Function
Atirmociclib administered as a single oral dose
Medicin: Atirmociclib
atirmociclib administered as a single oral dose
Andre navne:
  • PF-07220060
Eksperimentel: Group 2: Mild Hepatic Impairment
Atirmociclib administered as a single oral dose
Medicin: Atirmociclib
atirmociclib administered as a single oral dose
Andre navne:
  • PF-07220060
Eksperimentel: Group 3: Moderate Hepatic Impairment
Atirmociclib administered as a single oral dose
Medicin: Atirmociclib
atirmociclib administered as a single oral dose
Andre navne:
  • PF-07220060
Eksperimentel: Group 4: Severe Hepatic Impairment
Atirmociclib administered as a single oral dose
Medicin: Atirmociclib
atirmociclib administered as a single oral dose
Andre navne:
  • PF-07220060

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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 - ∞).
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
Tidsramme: 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 - ∞).
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

Sekundære resultatmål

Resultatmål
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events
Tidsramme: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of atirmociclib
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
Tidsramme: Baseline and Day 2, Day 7 after a single oral dose of atirmociclib
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
Tidsramme: Baseline and Day 2, Day 9 after a single oral dose of atirmociclib
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
Tidsramme: Predose and at 4, 144 hours after a single oral dose of atirmociclib
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
Tidsramme: Predose and at 4, 192 hours after a single oral dose of atirmociclib
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
Tidsramme: Predose and at 4, 144 hours after a single oral dose of atirmociclib
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
Tidsramme: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Predose and at 4, 192 hours after a single oral dose of atirmociclib

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

9. juli 2026

Primær færdiggørelse (Anslået)

14. august 2027

Studieafslutning (Anslået)

10. september 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C4391014

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nedsat leverfunktion

Kliniske forsøg med Atirmociclib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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