CompletedPhase 1

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

United States, Germany51 participantsStarted 2025-05-28

Plain-language 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).

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels (\> 40 mIU/mL).
✓. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.

What they're measuring

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Trial details

NCT IDNCT06942936

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-28

View on ClinicalTrials.gov More Healthy Participants trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels (\> 40 mIU/mL).
✓. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.

What they're measuring

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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

Timeframe: Day 1 and Day 10

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