Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.
Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.
Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Trial Information Desk
- Numéro de téléphone: +4588773600
- E-mail: clinicaltrials@zealandpharma.com
Lieux d'étude
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Poland
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Wroclaw, Poland, Pologne, 51-162
- Recrutement
- Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
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Contact:
- Piotr Napora, Dr.
- Numéro de téléphone: +483267900
- E-mail: napora.piotr@cbk.wroc.pl
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Bratislava Region
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Bratislava, Bratislava Region, Slovaquie, 831 01
- Recrutement
- Summit Clinical Research s.r.o.
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Contact:
- Viera Kupčová, Dr.
- Numéro de téléphone: +421905286213
- E-mail: viera.kupcova@summit-cr.eu
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Malacky
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Malacky, Malacky, Slovaquie, 901 01
- Recrutement
- Summit Clinical Research s.r.o.
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Contact:
- Edita Kadlubiaková, Dr.
- Numéro de téléphone: +421905434699
- E-mail: edita.kadlubiakova@summit-cr.eu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
All participants:
- Sex: male and female participants.
Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.
Additional Inclusion Criteria for Participants with Normal Hepatic Function
- Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
Additional Inclusion Criteria for Participants with Hepatic Impairment
- Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
- Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus [T2DM] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram [ECG], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
- Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.
Exclusion Criteria:
All participants:
- Known or suspected hypersensitivity to the IMP or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Petrelintide: Normal Hepatic Function
Participants with normal hepatic function will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Autres noms:
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Expérimental: Petrelintide: Mild HI
Participants with mild HI will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Autres noms:
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Expérimental: Petrelintide: Moderate HI
Participants with moderate HI will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Autres noms:
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Expérimental: Petrelintide: Severe HI
Participants with severe HI will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Maximum Observed Plasma Concentration (Cmax) of Petrelintide
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Time to Cmax (tmax)
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Apparent Clearance (CL/F) of Petrelintide
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Terminal Elimination Half-life (t1/2) of Petrelintide
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
Délai: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Délai: Day 1 up to Day 50
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Day 1 up to Day 50
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Clinical Trial Information Desk, Zealand Pharma A/S
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ZP8396-25077
- Universal Trial number (Autre identifiant: U1111-1328-8578)
- 2025-523641-10-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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