MedTrace Logo

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

NCT04492709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-11-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Midazolam

The subjects will receive single doses of midazolam solution 2 mg/mL orally on Day 1 alone in Treatment Period 1 and on Day 7 co-administered with oral AZD5718 tablet in Treatment Period 3.

DRUG

AZD5718

The subjects will receive oral AZD5718 tablet once daily starting on Day 2 to Day 6 in Treatment Period 2 and on Day 7 co-administered with midazolam in Treatment Period 3.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Dr. Pablo Forte Soto, MD, MSc, PhD · Parexel Early Phase Clinical Unit London

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2020-10-19
Completion
2020-10-19

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492709 on ClinicalTrials.gov