AZD5004 for Drug Interaction Study in Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Liver disease, Diabetes, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 19

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the new drug AZD5004 interacts with common medications like statins and repaglinide, and how erythromycin affects AZD5004 itself. The trial aims to understand how these drugs work together in the body, which can help doctors prescribe them more safely and effectively. Healthy men and women with a body mass index (BMI) between 20 and 35 and no history of major diseases might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves drug interactions, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

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

Research has shown that AZD5004, when tested on healthy individuals, did not cause any serious side effects. However, some participants experienced more frequent stomach issues as the dose increased. This suggests that while AZD5004 appears generally safe, higher doses might lead to stomach discomfort.

Erythromycin, a well-known antibiotic, has been used for many years. It is usually safe, but like most medications, it can cause side effects such as stomach upset or diarrhea in some people.

This trial tests both AZD5004 and Erythromycin together to observe their interaction. Previous studies indicate that AZD5004 is generally well-tolerated, with some concerns at higher doses, while Erythromycin is already approved and commonly used, though it can cause mild side effects in some individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD5004 because it offers a different approach to managing drug interactions, particularly with statins and other medications. Unlike standard treatments that might focus solely on efficacy within their class, AZD5004 is being explored for its potential to safely enhance the effects of widely-used medications like rosuvastatin, atorvastatin, and simvastatin. This study aims to uncover how AZD5004, through its unique mechanism, interacts with these drugs, potentially leading to more effective and safer combination therapies. Additionally, the exploration of AZD5004 with erythromycin and repaglinide might reveal new insights into optimizing drug regimens, which could be a game-changer for patients needing multiple medications.

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

This trial will study AZD5004 to understand its effects on other medications in the body. Participants will receive AZD5004 with various drugs, including rosuvastatin, erythromycin, simvastatin, atorvastatin, and repaglinide, across different study parts. Previous studies have examined AZD5004's interactions with drugs in healthy individuals, which is important for understanding its overall effects. Researchers have tested its safety and tolerability in adults with obesity, showing promising results. While this study focuses on drug interactions, existing research builds confidence in its safety for other uses. No specific data yet exists on its effects on the drugs tested in this study, but understanding these interactions could be crucial for future treatments. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for healthy adult men and women. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial

I have tested negative for pregnancy before starting the trial.

I agree to use effective birth control if there's a chance I could get pregnant.

Exclusion Criteria

History of Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening

Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis at the Screening Visit or on admission to the Clinical Unit

Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive rosuvastatin and AZD5004, and later erythromycin in multiple treatment periods

9 weeks

8 treatment periods

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Part B

Participants receive atorvastatin, simvastatin, and AZD5004 in multiple treatment periods

6 weeks

7 treatment periods

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Part C

Participants receive repaglinide and AZD5004 in multiple treatment periods

5 weeks

4 treatment periods

Follow-up Part C

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• AZD5004
• Erythromycin

Trial Overview The study is testing how AZD5004 affects other medications like Rosuvastatin, Atorvastatin, Simvastatin, and Repaglinide. It's also looking at how Erythromycin influences AZD5004 in the bodies of healthy people.

How Is the Trial Designed?

Group I: Part C Experimental Treatment 2 Interventions

Participants will receive 0.5 mg repaglinide initially during Period 1, later AZD5004 once daily will be administered . Participants will then receive 0.5 mg repaglinide with single dose of AZD5004 in Period 2, later two different doses of AZD5004 once daily will be administered. In Period 3, participants will receive 0.5 mg repaglinide with single dose of AZD5004 initially, and later AZD5004 once daily will be administered. In Period 4, participants will receive 0.5 mg repaglinide with single dose of AZD5004.

Group II: Part B Experimental Treatment 3 Interventions

Participants will receive 20 mg simvastatin during Period 1. In Period 2, participants will receive 40mg atorvastatin. In Period 3, participants will receive 40 mg atorvastatin and then, AZD5004 once daily . During Period 4, participants will receive 40 mg atorvastatin with single dose of AZD5004 and later, two different doses of AZD5004 alone will be administered once a day. In Period 5, participants will receive 20 mg simvastatin with single dose of AZD5004, later, AZD5004 alone will be administered once a day. During Period 6, participants will receive 40 mg atorvastatin with single dose of AZD5004 initially, and later AZD5004 will be administered once daily. In Period 7, participants will receive AZD5004 followed by 40 mg single dose of atorvastatin.

Group III: Part A Experimental Treatment 3 Interventions

Participants will receive 10 mg rosuvastatin in Period 1. Participants will receive 10 mg rosuvastatin and AZD5004 in Period 2. Later, participants will receive different doses of AZD5004 followed by 10 mg single dose of rosuvastatin in Period 3, Period 4, Period 5, and Period 6. In Period 7, participants will receive AZD5004 alone and later, 500 mg erythromycin twice a day. Participants will receive 500 mg erythromycin co-administered with AZD5004 during Period 8.

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

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7260C00001

Effects of AZD5004 in adults who are living with obesity ... A Phase IIb randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in participants living with obesity ...

2. tipranks.com tipranks.com/news/company-announcements/astrazenecas-latest-clinical-study-evaluating-azd5004s-impact-on-drug-interactions

AstraZeneca's Latest Clinical Study: Evaluating AZD5004's ... The study aims to evaluate how AZD5004 affects the pharmacokinetics of several drugs in healthy individuals, which could have significant ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06579105

NCT06579105 | Efficacy, Safety, and Tolerability of Once ... This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/34006656/astrazenecas-new-study-on-azd5004-potential-market-implications/

AstraZeneca's New Study on AZD5004: Potential Market ... The study's primary objective is to understand how AZD5004 affects the pharmacokinetics of these drugs in healthy individuals, which is crucial ...

5. ctv.veeva.com ctv.veeva.com/study/effects-of-azd5004-in-adults-who-are-living-with-obesity-or-overweight-with-at-least-1-weight-relate

Effects of AZD5004 in Adults Who Are Living With Obesity or ... A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with ...

6. tipranks.com tipranks.com/news/company-announcements/astrazenecas-latest-study-on-azd5004-key-insights-for-investors

AstraZeneca's Latest Study on AZD5004: Key Insights for ... This study is significant as it explores potential drug interactions, which are crucial for patient safety and effective treatment regimens.

7. biospace.com biospace.com/drug-development/astrazeneca-bolsters-obesity-pipeline-with-promising-early-data-for-candidates

AstraZeneca Bolsters Obesity Pipeline With Promising ... AZD5004 in healthy participants did not result in serious adverse events, while gastrointestinal toxicities became increasingly common at doses ...