Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Healthy Participants
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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...
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: performe...
Eligibility Criteria
Inclusion
- Main
- Part A -
- Suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating, must agree to use approved method of contraceptive.
- Sexually active fertile male participants with female partners of childbearing potential must adhere to the approved contraception methods.
- Have a Body Mass Index (BMI) between ≥ 18.5 kg/m2 and ≤ 35 kg/m2 (at the time of screening) and weigh at least 50 kg.
- Part B -
- Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following 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.
- Have a BMI between ≥ 23 kg/m2 and ≤ 30 kg/m2 and weigh at least 55 kg.
- Main
Exclusion
- Part A and Part B-
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study.
- History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase at screening.
- History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Abnormal laboratory values, hepatic disease, Human Immunodeficiency Virus (HIV) positive, abnormal vital signs, abnormalities in rhythm, uncontrolled thyroid disease.
- Known smoker, history of alcohol, drug abuse or caffeine intake.
- Use of prescribed or unsubscribed medication within 3 months prior to screening.
- History of psychosis, bipolar disorder, major depressive disorder.
- Vulnerable participants, e.g., kept in detention, protected adults under guardianship.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06942936
Start Date
May 28 2025
End Date
January 28 2026
Last Update
December 18 2025
Active Locations (2)
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1
Research Site
Baltimore, Maryland, United States, 21225
2
Research Site
Berlin, Germany, 14050