Itraconazole and AZD5004 for Drug Interaction Study

Not currently recruiting at 1 trial location

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Prescribed medications

Disqualifiers: HIV, Hepatic disease, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how itraconazole, a medication, affects the breakdown of AZD5004 (an experimental treatment) in the body and how AZD5004 influences the effectiveness of common birth control pills. It consists of two parts: Part A examines the interaction between itraconazole and AZD5004, while Part B investigates AZD5004's effect on birth control pills in women. Ideal participants for Part A are healthy individuals who can undergo blood draws, and for Part B, healthy women who cannot become pregnant. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that participants have not used any prescribed or non-prescribed medication within 3 months prior to screening, so you will likely need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that itraconazole, one of the treatments in this trial, is generally safe for people. However, it can interact with other medicines, especially those processed by the liver, which can sometimes cause problems. Therefore, monitoring is important. Safety data from previous studies with 602 patients indicate that itraconazole is usually well-tolerated when used correctly.

For AZD5004, direct safety data remains limited. Since this trial is in its early stages, it primarily focuses on how AZD5004 interacts with other drugs, resulting in limited information on its safety in humans so far.

When combined with ethinyl estradiol/levonorgestrel (a type of birth control pill), it's important to note that while the pill is widely used, it can have side effects. For example, smoking while taking these pills can increase the risk of blood clots or heart problems. Overall, the safety of AZD5004 is still under study, and participants will be closely monitored during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike many current treatments that focus on a single drug, the combination of AZD5004 and Itraconazole offers a unique approach by investigating potential interactions between these drugs. Researchers are excited because AZD5004, a new active ingredient, could potentially enhance or alter the effects of existing medications like Itraconazole, which is commonly used as an antifungal agent. In the second treatment arm, the combination of AZD5004 with Ethinyl Estradiol/Levonorgestrel (EE/LNG) is equally intriguing, as it explores the interaction between this novel compound and a widely used contraceptive, possibly leading to new insights in drug synergy and safety profiles. These studies aim to uncover how AZD5004 can be safely integrated with other drugs, potentially leading to more effective treatment protocols.

What evidence suggests that this trial's treatments could be effective?

This trial will study how AZD5004 interacts with other medications. Participants in Part A will receive AZD5004 alone, then Itraconazole alone, and finally a combination of AZD5004 with Itraconazole. Previous research suggests that taking AZD5004 with Itraconazole may alter how AZD5004 is processed in the body, potentially affecting its effectiveness and side effects. In Part B, the trial will examine how AZD5004 affects the body's processing of birth control pills. These studies aim to determine if AZD5004 changes the effectiveness or safety of these other medications. Although definite results are not yet available, this research helps determine how AZD5004 can be used safely with other drugs. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy individuals. Part A includes any gender, while Part B is specifically for healthy females who are eligible to take combined oral contraceptives.

Inclusion Criteria

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 ≤ 35 kg/m2 and weigh at least 55 kg

My veins can be used for repeated needle insertions.

I have tested negative for pregnancy before starting the trial.

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

Known smoker, history of alcohol, drug abuse or caffeine intake

Vulnerable participants, e.g., kept in detention, protected adults under guardianship

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

27 days

Treatment Part A

Participants receive AZD5004, followed by Itraconazole, and then a combination of both

10 days

Multiple visits for drug administration and monitoring

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment

17 to 24 days

Treatment Part B

Participants receive combined oral contraceptives and AZD5004

78 days

Visits on Day 1, Day 8, Day 50, and Day 78

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

Up to 96 days

What Are the Treatments Tested in This Trial?

Interventions

• AZD5004
• Itraconazole

Trial Overview

The study tests how multiple doses of the antifungal drug Itraconazole affect AZD5004 in participants (Part A), and how AZD5004 affects the body's handling of birth control pills containing Ethinyl Oestradiol and Levonorgestrel in female participants (Part B).

How Is the Trial Designed?

Group I: Part B: Ethinyl Estradiol/ Levonorgestrel (EE/LNG) + AZD5004 Experimental Treatment 2 Interventions

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

Group II: Part A: AZD5004 + Itraconazole Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

A retrospective review of patients treated with itraconazole revealed that low serum levels of the drug were linked to treatment failures in serious fungal infections, such as disseminated histoplasmosis and invasive aspergillosis.

Factors like concurrent use of rifampin, medications that reduce stomach acid, and specific administration methods (like nasogastric tubes) contributed to these low levels, suggesting that monitoring serum itraconazole levels is crucial for patients at risk of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Itraconazole: Precautions regarding drug interactions and bioavailability. Puttick, MP., Phillips, P.[2021]

Citations

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NCT06942936 | A Study to Investigate the Impact of ...

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.

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A Study to Investigate the Impact of Multiple Doses ... - MedPath

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) ...

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AstraZeneca's Latest Study: Exploring Drug Interactions ...

The study aims to evaluate how multiple doses of Itraconazole affect the pharmacokinetics of AZD5004 and how AZD5004 impacts the pharmacokinetics of combined ...

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Itraconazole and AZD5004 for Drug Interaction Study

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) ...

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Drug Interaction - Oral Contraceptive (NCT00399685) - ClinConnect

The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz ...

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drugs.com/drug-interactions/ethinyl-estradiol-levonorgestrel.html

Ethinyl estradiol/levonorgestrel Interactions

There are 503 drugs known to interact with ethinyl estradiol/levonorgestrel, along with 22 disease interactions, and 9 alcohol/food interactions. Of the total ...

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Levonorgestrel and ethinyl estradiol (oral route)

If you smoke while using ethinyl estradiol and norgestrel combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even ...

8.

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levonorgestrel and ethinyl estradiol tablets - accessdata.fda.gov

7 DRUG INTERACTIONS. The sections below provide information on substances for which data on drug interactions with. CHCs are available. There is little ...

9.

medlineplus.gov

medlineplus.gov/druginfo/meds/a625049.html

Ethinyl Estradiol and Levonorgestrel (Oral Contraceptives)

Ethinyl estradiol and levonorgestrel oral contraceptives may cause heart attacks, blood clots, and strokes. Tell your doctor if you smoke ...

10.

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dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6e686b50-8d36-4a13-91a8-d4ad21cdb735

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/ ...

Levonorgestrel and ethinyl estradiol tablets is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally ...