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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Trial Information Desk
- Telefonnummer: +4588773600
- E-post: clinicaltrials@zealandpharma.com
Studiesteder
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Poland
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Wroclaw, Poland, Polen, 51-162
- Rekruttering
- Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
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Ta kontakt med:
- Piotr Napora, Dr.
- Telefonnummer: +483267900
- E-post: napora.piotr@cbk.wroc.pl
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Bratislava Region
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Bratislava, Bratislava Region, Slovakia, 831 01
- Rekruttering
- Summit Clinical Research s.r.o.
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Ta kontakt med:
- Viera Kupčová, Dr.
- Telefonnummer: +421905286213
- E-post: viera.kupcova@summit-cr.eu
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Malacky
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Malacky, Malacky, Slovakia, 901 01
- Rekruttering
- Summit Clinical Research s.r.o.
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Ta kontakt med:
- Edita Kadlubiaková, Dr.
- Telefonnummer: +421905434699
- E-post: edita.kadlubiakova@summit-cr.eu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Day 1 up to Day 50
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Day 1 up to Day 50
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Clinical Trial Information Desk, Zealand Pharma A/S
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ZP8396-25077
- Universal Trial number (Annen identifikator: U1111-1328-8578)
- 2025-523641-10-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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