Pure Global
NCT04492709

A Study to Assess the Effect of Multiple Doses of AZD5718 on Pharmacokinetics of Oral Midazolam in Healthy Subjects

A Fixed Sequence, Open-Label Study to Assess the Effect of Multiple Doses of AZD5718 on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Healthy Subjects
AstraZeneca·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Cardiovascular Disease
Drug/Device/Intervention
Midazolam
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Harrow, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Jul 30, 2020
End date
Oct 19, 2020
Enrollment
14 participants
Primary outcome

Maximum observed plasma peak concentration (Cmax) of midazolam,Area under plasma concentration-time curve from time zero to infinity (AUCinf) of midazolam,Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of midazolam,Time to reach maximum observed plasma concentration (tmax) of midazolam,Half-life (t1/2) of midazolam,Plasma concentrations of AZD5718

Summary

In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is
 important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4
 substrates. The primary objective of this study is to evaluate the effect of AZD5718 on the
 PK of midazolam, a known sensitive CYP3A4 substrate.

ICD-10 classifications
Cardiovascular disease, unspecifiedHypertensive heart diseaseHeart disease, unspecifiedAtherosclerotic cardiovascular disease, so describedAtherosclerotic heart disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04492709
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04492709 through Pure Global AI's free database. This Phase 1 trial is sponsored by AstraZeneca and is currently Completed. The study focuses on Cardiovascular Disease. Target enrollment is 14 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.