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AZD4205 and itraconazole for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Dizal Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 days after study drug administration

Awards & highlights

Study Summary

This trial is testing how well a new drug, AZD4205, works when taken with other drugs that either inhibit or induce activity of the CYP3A4 enzyme. The trial will enroll healthy adults in two parts. In Part A, subjects will receive multiple doses of itraconazole, a CYP3A4 enzyme inhibitor. In Part B, subjects will receive multiple doses of carbamazepine, a CYP3A4 inducer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 days after study drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 days after study drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days after study drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with carbamazepine (Part B)

Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A)

Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: AZD4205 and itraconazoleExperimental Treatment1 Intervention

Subjects in arm 2 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period.

Group II: AZD4205 and carbamazepineExperimental Treatment1 Intervention

Subjects in arm 1 will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD4205 and itraconazole

2022

Completed Phase 1

~40

AZD4205 and carbamazepine

2022

Completed Phase 1

~40

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dizal PharmaceuticalsLead Sponsor

20 Previous Clinical Trials

2,017 Total Patients Enrolled

Shirlian XuStudy DirectorDizal Pharma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which individuals is admission to this experiment open?

"This clinical study is seeking 32 individuals who meet the following criteria: willingness to partake in the trial, signed consent, and compliance with its guidelines; male or female between 18-55 years of age; BMI ranging from 18.0 to 30.0 kg/m2; males must weigh at least 55kgs while females have a minimum weight requirement of 45kgs.; healthy subjects (absence of major health conditions); no clinically significant haematological abnormalities; childbearing potential participants must practice protocol specified contraception methods and abide by pregnancy precautions as outlined in the document; abstain from consuming alcohol, caffeine, methylxanthines for"

Answered by AI

Are there any vacancies available for participants in this clinical trial?

"Affirmative, clinicaltrials.gov provides evidence that this experiment is actively seeking volunteers. It was first posted on July 27th 2022 and the most recent modifications were made August 2nd of the same year. 32 patients must be enrolled from a single site for full trial activation."

Answered by AI

Does this research study include elderly participants aged 75 or over?

"Eligibility for this medical trial is defined by age, with patients needing to be at least 18 years of age and younger than 55."

Answered by AI

Has the FDA sanctioned AZD4205 and itraconazole for medicinal applications?

"There is restricted evidence of safety and efficacy for AZD4205 and itraconazole, so they were given a score of 1."

Answered by AI

What is the aggregate amount of individuals participating in this experiment?

"Affirmative, the data on clinicaltrials.gov affirms that this research endeavour is currently accepting candidates. This trial was initially advertised on July 27th of 2022 and tweaked most recently on August 2nd of the same year. 32 volunteers are needed from a single location to take part in this experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Drug-drug Interactions Between AZD4205 and Itraconazole/Carbamazepine

2022. "Drug-drug Interactions Between AZD4205 and Itraconazole/Carbamazepine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05486949.