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 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
28
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lieux d'étude
-
-
Florida
-
Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Floridian Clinical Research
-
Orlando, Florida, États-Unis, 32809
- Recrutement
- Orlando Clinical Research Center
-
Tampa, Florida, États-Unis, 33603
- Recrutement
- Genesis Clinical Research
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1: Normal Hepatic Function
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Autres noms:
|
|
Expérimental: Group 2: Mild Hepatic Impairment
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Autres noms:
|
|
Expérimental: Group 3: Moderate Hepatic Impairment
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Autres noms:
|
|
Expérimental: Group 4: Severe Hepatic Impairment
Atirmociclib administered as a single oral dose
|
atirmociclib administered as a single oral dose
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
29 juin 2026
Achèvement primaire (Estimé)
14 août 2027
Achèvement de l'étude (Estimé)
10 septembre 2027
Dates d'inscription aux études
Première soumission
24 juin 2026
Première soumission répondant aux critères de contrôle qualité
24 juin 2026
Première publication (Réel)
30 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C4391014
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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