A Study to Assess the Effect of Multiple Doses of AZD5718 on Pharmacokinetics of Oral Midazolam in Healthy Subjects - Trial NCT04492709
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.
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Study Focus
Sponsor & Location
AstraZeneca
Timeline & Enrollment
Phase 1
Jul 30, 2020
Oct 19, 2020
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
Data Source
ClinicalTrials.gov
NCT04492709
Non-Device Trial