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
19 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
28
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Pfizer CT.gov Call Center
- Telefoonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studie Locaties
-
-
Florida
-
Miami Lakes, Florida, Verenigde Staten, 33016
- Werving
- Floridian Clinical Research
-
Orlando, Florida, Verenigde Staten, 32809
- Werving
- Orlando Clinical Research Center
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Tampa, Florida, Verenigde Staten, 33603
- Werving
- Genesis Clinical Research
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group 1: Normal Hepatic Function
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Andere namen:
|
|
Experimenteel: Group 2: Mild Hepatic Impairment
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Andere namen:
|
|
Experimenteel: Group 3: Moderate Hepatic Impairment
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Andere namen:
|
|
Experimenteel: Group 4: Severe Hepatic Impairment
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 juni 2026
Primaire voltooiing (Geschat)
14 augustus 2027
Studie voltooiing (Geschat)
10 september 2027
Studieregistratiedata
Eerst ingediend
24 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
24 juni 2026
Eerst geplaatst (Werkelijk)
30 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
19 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- C4391014
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .