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Healthy ParticipantsPhase 1NCT06942936

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

A Phase 1 study testing AZD5004, Itraconazole and EE/LNG in people with Healthy Participants, run by AstraZeneca at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
AZD5004, Itraconazole and EE/LNG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesin 2 countries
Study dates
28 May 2025to 28 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Main 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.

Main 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Research Site

    Baltimore, Maryland, 21225

Other trials in United States

Germany1 site

  • Research Site

    Berlin, 14050

Other trials in Germany

About this study

Official title: An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

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).

Read the 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
Being tested
AZD5004, Itraconazole, EE/LNG
Keywords
Obesity, Type 2 Diabetes
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5004Drug

    AZD50004 is administered orally as a tablet.

  • ItraconazoleDrug

    Itraconazole is administered orally as a capsule.

  • EE/LNGDrug

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

Study groups in NCT06942936
Study groupRoleWhat they receive
Part A: AZD5004 + ItraconazoleExperimentalParticipants 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.
Receives: Drug: AZD5004; Drug: Itraconazole
Part B: Ethinyl Estradiol/ Levonorgestrel (EE/LNG) + AZD5004ExperimentalParticipants will receive one tablet of combined 0.03/0.15 mg EE/LNG and AZD5004 orally.
Receives: Drug: AZD5004; Drug: EE/LNG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 and Day 10

  2. 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

    Measured: Day 1 and Day 10

  3. 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

    Measured: Day 1 and Day 10

  4. 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

    Measured: Day 1 and Day 10

  5. 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

    Measured: Day 1 and Day 10

  6. 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

    Measured: Day 1 and Day 10

  7. 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

    Measured: Day 1 and Day 10

  8. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

  9. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

  10. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

  11. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

  12. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

  13. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

  14. 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

    Measured: Day 1, Day 8, Day 50 and Day 78

Secondary outcomes (5)

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

    To assess the safety and tolerability of AZD5004 alone and in combination with itraconazole in healthy male and female participants

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

  2. Part B: Number of patients with AEs

    To assess the safety and tolerability of AZD5004 alone and in combination with combined oral EE/LNG in healthy female participants

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

  3. Part B: AUCinf of AZD5004

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

    Measured: Days 8, Day 50 and Day 78

  4. Part B: AUClast of AZD5004

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

    Measured: Days 8, Day 50 and Day 78

  5. Part B: Cmax of AZD5004

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

    Measured: Day 8, Day 50 and Day 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study start28 May 2025
  3. Primary completion28 Jan 2026
  4. Study completion28 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942936
Sponsor's protocol ID
D7260C00007
Other IDs
2024-518467-35-00
Status last verified
Jan 2026
First submitted
17 Apr 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD5004, Itraconazole and EE/LNG in people with Healthy Participants, run by AstraZeneca at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Area under concentration-time curve from time zero to infinity (AUCinf) of AZD5004 (time frame: Day 1 and Day 10). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06942936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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