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 | Completed Phase 1 FDA Drug

• 2 other identifiers: D7260C000072024-518467-35-00
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 2

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).

Conditions

Healthy Participants

Keywords

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (14)

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

  To assess the effect of multiple doses of itraconazole on the AUCinf of a single dose of AZD5004 in healthy male and female participants.

  Day 1 and Day 10

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

  To assess the effect of multiple doses of itraconazole on the AUClast of a single dose of AZD5004 in healthy male and female participants

  Day 1 and Day 10

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

  To assess the effect of multiple doses of itraconazole on the Cmax of a single dose of AZD5004 in healthy male and female participants

  Day 1 and Day 10

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

  To assess the effect of multiple doses of itraconazole on the t1/2λz of a single dose of AZD5004 in healthy male and female participants

  Day 1 and Day 10

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

  To assess the effect of multiple doses of itraconazole on the tmax of a single dose of AZD5004 in healthy male and female participants

  Day 1 and Day 10

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

  To assess the effect of multiple doses of itraconazole on the CL/F of a single dose of AZD5004 in healthy male and female participants

  Day 1 and Day 10

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

  To assess the effect of multiple doses of itraconazole on the Vz of a single dose of AZD5004 in healthy male and female participants

  Day 1 and Day 10

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

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the AUCinf of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

• Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of EE/LNG

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the AUClast of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

• Part B: Maximum observed drug concentration (Cmax) of EE/LNG

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the Cmax of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

• Part B: Terminal elimination half-life (t1/2λz) of EE/LNG

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the t1/2λz of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

• Part B: Time to reach maximum observed concentration (tmax) of EE/LNG

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the tmax of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

• Part B: Apparent total body clearance (CL/F) of EE/LNG

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the CL/F of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

• Part B: Apparent volume of distribution based on the terminal phase (Vz) of EE/LNG

  To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the Vz of single doses of combined oral EE/LNG in healthy female participants

  Day 1, Day 8, Day 50 and Day 78

Secondary Outcomes (5)

• Part A: Number of patients with Adverse Events (AEs)

  From Screening (Day -2 to Day -28) to Day 27

• Part B: Number of patients with AEs

  From Screening (Day -2 to Day -28) to Day 96

• Part B: AUCinf of AZD5004

  Days 8, Day 50 and Day 78

• Part B: AUClast of AZD5004

  Days 8, Day 50 and Day 78

• Part B: Cmax of AZD5004

  Day 8, Day 50 and Day 78

Study Arms (2)

Part A: AZD5004 + Itraconazole

EXPERIMENTAL

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.

Drug: AZD5004; Drug: Itraconazole

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

EXPERIMENTAL

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

Drug: AZD5004; Drug: EE/LNG

Interventions

EE/LNG DRUG

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

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

AZD5004 DRUG

AZD50004 is administered orally as a tablet.

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

Itraconazole DRUG

Itraconazole is administered orally as a capsule.

Part A: AZD5004 + Itraconazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (2)

Research Site

Baltimore, Maryland, 21225, United States

Location

Research Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A and Part B are 2 independent and non-sequential parts (arms) in this study. Part A will be performed in healthy male and female participants. Part B will be performed in healthy female participants.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: May 28, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1); DE (1)