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
NCT06942936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2026-02-03
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).
Conditions
- Healthy Participants
Interventions
- 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.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-28
- Primary Completion
- 2026-01-28
- Completion
- 2026-01-28
- FDA Drug
- Yes
Countries
- United States
- Germany
Study Locations
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