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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Clinical Trial Information Desk
- Telefoonnummer: +4588773600
- E-mail: clinicaltrials@zealandpharma.com
Studie Locaties
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Poland
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Wroclaw, Poland, Polen, 51-162
- Werving
- Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
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Contact:
- Piotr Napora, Dr.
- Telefoonnummer: +483267900
- E-mail: napora.piotr@cbk.wroc.pl
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Bratislava Region
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Bratislava, Bratislava Region, Slowakije, 831 01
- Werving
- Summit Clinical Research s.r.o.
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Contact:
- Viera Kupčová, Dr.
- Telefoonnummer: +421905286213
- E-mail: viera.kupcova@summit-cr.eu
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Malacky
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Malacky, Malacky, Slowakije, 901 01
- Werving
- Summit Clinical Research s.r.o.
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Contact:
- Edita Kadlubiaková, Dr.
- Telefoonnummer: +421905434699
- E-mail: edita.kadlubiakova@summit-cr.eu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Day 1 up to Day 50
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Day 1 up to Day 50
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Clinical Trial Information Desk, Zealand Pharma A/S
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- ZP8396-25077
- Universal Trial number (Andere identificatie: U1111-1328-8578)
- 2025-523641-10-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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