NCT05551897

A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole

An Open-Label, Fixed Sequence Study in Healthy Post Menopausal Female Subjects to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.

Detailed description

This open-label, fixed sequence study will comprise of: * A screening period of 28 days; * A fixed sequence of three treatment period: Treatment Period 1: Camizestrant only, Treatment Period 2: Itraconazole only, Treatment Period 3: Camizestrant and Itraconazole in combination. • A Follow-up Visit at 7 to 14 days after the last Camizestrant PK sample in Period 3. There will be a washout period of 7 to 10 days between Period 1 and Period 2. Each subject will be involved in the study for approximately 8 or 9 weeks.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Camizestrant	Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.
DRUG	Itraconazole	Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3.

Timeline

• Start date: 2022-10-04
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2022-09-23
• Last updated: 2023-01-06

Locations

1 site across 1 country: United Kingdom