A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234

Официальное название

A Phase I, Single-Dose, Open-Label, Sequential, Randomised, Crossover Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD6234 in Participants Living With Overweight or Obesity

Обзор

This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234. This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.

Подробное описание

This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234.

This study will take place at one site in Nottingham, United Kingdom.

It plans to enrol 21 healthy men and women aged 18-55 years.

Each volunteer will take part in 4 treatment periods and receive different formulations of AZD6234, by injection under the skin into the abdomen (stomach). In each period they'll be given a single dose without food. They'll stay in the clinic for 6 nights on 4 occasions, attend up to 10 outpatient visits, and take up to 19 weeks to finish the study.

Blood and urine samples will be collected to: measure the amount of AZD6234 and its breakdown products, do safety tests and assess the effect of the test medicine on the immune system response.

Вмешательства

• Препарат AZD6234 Formulation 1
  AZD6234 Formulation 1 will be administered as a single SC injection
• Препарат AZD6234 Formulation 2 (low concentration)
  AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
• Препарат AZD6234 Formulation 2 (high concentration)
  AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
• Препарат AZD6234 Formulation 3
  AZD6234 Formulation 3 will be administered as a single SC injection

Первичные конечные точки

• Maximum observed plasma concentration (Cmax) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]
• Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]
• Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]

Вторичные конечные точки (5)

• Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests [Срок оценки: Through study duration, approximately 19 weeks]
• Time of maximum observed plasma concentration (tmax) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]
• Terminal elimination half-life (t1/2) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]
• Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]
• Volume of distribution based on the terminal phase calculated using AUC0-inf after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) [Срок оценки: Plasma sample collection from pre- dose to 30 days post final dose]

Критерии участия

Критерии включения

• Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
• BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg

Критерии исключения

• History of any clinically important disease or disorder
• History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or gastrointestinal disorder including a history of pancreatitis or gall stones
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the planned first dosing day
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
• Any clinically significant abnormal findings in vital signs
• Any clinically significant abnormalities on 12-lead ECG
• HbA1c ≥6.5% (≥48 mmol/mol)
• Evidence of renal impairment
• Females who are pregnant or lactating.
• Any participant who has received an amylin analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer)
• Participants who report to have previously received AZD6234.
• Use of any prescribed or non-prescribed medication

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Research Site — Ruddington

Идентификаторы

NCT: NCT07220954 · D8750C00008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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