AZD4205 and itraconazole for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pharmaceutical Research Associates, Inc., Lenexa, KS
Healthy Subjects (HS)
AZD4205 and carbamazepine - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence, drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A) and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single dose PK of AZD4205 in healthy adult subjects (Part B).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: up to 10 days after study drug administration

Day 10
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 time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B)
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Day 18
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 itraconazole (Part A)
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

2 Treatment Groups

AZD4205 and itraconazole
1 of 2
AZD4205 and carbamazepine
1 of 2
Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: AZD4205 and itraconazole · No Placebo Group · Phase 1

AZD4205 and itraconazole
Drug
Experimental Group · 1 Intervention: AZD4205 and itraconazole · Intervention Types: Drug
AZD4205 and carbamazepine
Drug
Experimental Group · 1 Intervention: AZD4205 and carbamazepine · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 days after study drug administration
Closest Location: Pharmaceutical Research Associates, Inc. · Lenexa, KS
2016First Recorded Clinical Trial
5 TrialsResearching Healthy Subjects (HS)
12 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to participate in the study and give written informed consent.
You are between the ages of 18 and 55 years.
BMI > 18.0 kg/m2, inclusive.
You are healthy.
You are free of any disease that would affect your ability to participate in the study.
You have no clinically significant hematological or coagulation abnormalities, as judged by the investigator.
Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception and comply with pregnancy precautions as described in the protocol.
You are able to abstain from alcohol-, caffeine-, and methylxanthine containing beverages or food from 72 hours (3 days) prior to admission until discharge from the clinical facility.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.