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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female participants.

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 AZD5004 (azithromycin) safe for humans?

Azithromycin, which is related to AZD5004, is generally considered safe and does not significantly interact with other drugs, unlike erythromycin, which can cause drug interactions and side effects like low blood pressure when combined with certain medications. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of the effects of the new azalide antibiotic, azithromycin, and erythromycin estolate on rat liver cytochrome P-450. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A guide to selection and appropriate use of macrolides in skin infections. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Calcium channel blockers + macrolides: elderly patients hospitalised for low blood pressure. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Drug interactions with azithromycin and the macrolides: an overview. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic drug interactions of macrolides. [2022]