A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole

Healthy Volunteers Clinical Trial

Official title: An Open-label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole

Status Completed

Clinical Trial Summary

A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.

Clinical Trial Description

This will be a an open-label, 3-period fixed sequence study to be conducted at a single study centre.

The treatment starts with AZD4831 (Treatment Period 1), followed by Itraconazole administration for 3 days (Treatment Period 2) and finally a combination of AZD4831+Itraconazole administration (Treatment Period 3).

The study will comprise of:

• A Screening Period of approximately 28 days.

• Three Treatment Periods:

• Treatment Period 1 (Day -1 through pre-dose Day 8): Single oral dose of AZD4831 only on Day 1,

• Treatment Period 2 (Day 8 through pre-dose Day 11): Oral dose of Itraconazole only on Days 8 through 10,

• Treatment Period 3 (Day 11 through Day 18, after the last PK sample is collected):

AZD4831 and Itraconazole on Day 11 and oral dosing of Itraconazole only on Days 12 through 17.

• A final Follow-up Visit after the last PK sample (Day 25 to Day 32).

Each subject will be involved in the study for approximately 9 weeks (including the 28 day Screening Period). ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05236543
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: February 18, 2022
• Completion date: August 12, 2022