Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants

Официальное название

An Open-label, Randomised, Two Arm, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD4144 When Administered Alone and in Combination With Itraconazole

Обзор

The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.

Подробное описание

This is an open-label, randomised, two arm, 3 period, fixed sequence study in healthy participants.

The study will include two parallel, independent arms with one arm evaluating oral administration of AZD4144 and the other evaluating AZD4144 administered as an intravenous (IV) infusion.

Each study arm will comprise of:

1. A screening period of up to 28 days. 2. Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole. 3. A final follow-up visit.

Вмешательства

• Препарат AZD4144
  AZD4144 will be administered orally.
• Препарат AZD4144
  AZD4144 will be administered as an IV infusion.
• Препарат Itraconazole
  Itraconazole will be administered orally.

Первичные конечные точки

• Area under concentration time curve from time 0 to infinity (AUCinf) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Maximum observed drug concentration (Cmax) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]

Вторичные конечные точки (6)

• Total body clearance (CL) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Apparent total body clearance (CL/F) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Volume of distribution during the terminal phase (Vz) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Apparent volume of distribution based on the terminal phase (Vz/F) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Terminal elimination half life (t½λz) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]
• Time to reach maximum observed concentration (tmax) [Срок оценки: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16]

Критерии участия

Критерии включения

• Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
• Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
• Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.
• Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.

Критерии исключения

• Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
• History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
• Any clinically important illness, medical/surgical procedure, or trauma.
• Active systemic bacterial, viral, or fungal infection.
• Clinically significant serious active or chronic infections.
• Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
• Concomitant immunosuppressive, steroid treatment.
• Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.
• Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.
• Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07685600 · D9440C00006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗