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

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NCT06942936

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Parexel.

Phase

Phase 1

Status

Completed

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

51actual

Sites

Countries

Germany, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-05-28

actual

When the study began enrolling

Primary completion

2026-01-28

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-01-28

actual

The whole study's end, after follow-up

First posted

2025-04-24

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-02-03

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Healthy Participants

Interventions

Drug: AZD5004
Drug: Itraconazole
Drug: EE/LNG

Primary outcomes

what the primary-completion date above is the date OF

Part A: Area under concentration-time curve from time zero to infinity (AUCinf) of AZD5004

measured Day 1 and Day 10

Part A: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD5004

measured Day 1 and Day 10

Part A: Maximum observed drug concentration (Cmax) of AZD5004

measured Day 1 and Day 10

Part A: Terminal elimination half-life (t1/2λz) of AZD5004

measured Day 1 and Day 10

Part A: Time to reach maximum observed concentration (tmax) of AZD5004

measured Day 1 and Day 10

Part A: Apparent total body clearance (CL/F) of AZD5004

measured Day 1 and Day 10

Part A: Apparent volume of distribution based on the terminal phase (Vz) of AZD5004

measured Day 1 and Day 10

Part B: Area under concentration-time curve from time zero to infinity (AUCinf) of EE/LNG