NCT06942936

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the impact of multiple doses of itraconazole on the pharmacokinetics (PK) of AZD5004 in healthy participants (Part A), and to assess the impact of multiple doses of AZD5004 on the PK of Combined Oral Contraceptives (COCs) in healthy female participants (Part B).

Detailed description

This study will be an open-label, fixed-sequence, two-part study in healthy participants. There are 2 parts in this study: Part A: performed in healthy male and female participants. Part B: performed in healthy female participants. Part A will consist of: 1. Screening period of 27 days 2. Period 1 3. Period 2 4. Period 3 5. Follow-up period of 17 to 24 days after the last AZD5004 dose Part B will consist of: 1. Screening period of 27 days 2. Start of study period 3. Up-titration period 4. End of study period 5. Follow-up

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004	AZD50004 is administered orally as a tablet.
DRUG	Itraconazole	Itraconazole is administered orally as a capsule.
DRUG	EE/LNG	EE/LNG is administered orally in the form of tablet.

Timeline

• Start date: 2025-05-28
• Primary completion: 2026-01-28
• Completion: 2026-01-28
• First posted: 2025-04-24
• Last updated: 2026-02-03

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study