Itraconazole and AZD5004 for Drug Interaction Study
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive AZD5004, followed by Itraconazole, and then a combination of both
Follow-up Part A
Participants are monitored for safety and effectiveness after treatment
Treatment Part B
Participants receive combined oral contraceptives and AZD5004
Follow-up Part B
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD5004
- Itraconazole
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
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