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

NCT ID: NCT06942936

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2026-01-28

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 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

Keywords

Obesity; Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: AZD5004 + Itraconazole

Participants will receive oral dose of AZD5004 on Period 1, followed by Itraconazole capsule orally in Period 2, and then will receive oral dose of AZD5004 combination with Itraconazole capsule in Period 3.

Group Type: EXPERIMENTAL

AZD5004

Intervention Type: DRUG

AZD50004 is administered orally as a tablet.

Itraconazole

Intervention Type: DRUG

Itraconazole is administered orally as a capsule.

Part B: Ethinyl Estradiol/ Levonorgestrel (EE/LNG) + AZD5004

Participants will receive one tablet of combined 0.03/0.15 mg EE/LNG and AZD5004 orally.

Group Type: EXPERIMENTAL

AZD5004

Intervention Type: DRUG

AZD50004 is administered orally as a tablet.

EE/LNG

Intervention Type: DRUG

EE/LNG is administered orally in the form of tablet.

Interventions

AZD5004

AZD50004 is administered orally as a tablet.

Intervention Type: DRUG

Itraconazole

Itraconazole is administered orally as a capsule.

Intervention Type: DRUG

EE/LNG

EE/LNG is administered orally in the form of tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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:

1. 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).

2. 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Baltimore, Maryland, United States

Research Site

Berlin, , Germany

Countries

United States; Germany

Other Identifiers

2024-518467-35-00

Identifier Type: OTHER

Identifier Source: secondary_id

D7260C00007

Identifier Type: -

Identifier Source: org_study_id