NCT02010970

A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate

A Phase I, Single-center, Open-label, 3-group, Fixed-sequence Study to Assess the Effect of Itraconazole, a Potent CYP3A4 Inhibitor, or Diltiazem, a Moderate CYP3A4 Inhibitor, on the Pharmacokinetics of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a CYP3A4/CYP3A5 Substrate, in Healthy Young Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on the single-dose PK of AZD3293 and the effects of coadministration of single- and multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the safety and tolerability of single and multiple oral doses of AZD3293, alone and in combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is being developed for the treatment of Alzheimer's disease

Conditions

• Healthy Volunteers
• Pharmacologic Action

Interventions

Type	Name	Description
DRUG	Group 1 AZD3293	AZD3293 oral solution
DRUG	Group 2 AZD3293	AZD3293 oral solution
DRUG	Group 3 AZD3293	AZD3293 oral solution
DRUG	Group 1 Itraconazole	itraconazole capsule
DRUG	Group 2 Diltiazem	Diltiazem ER tablet
DRUG	Group 3 Midazolam	midazolam syrup

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-12-13
• Last updated: 2014-04-28

Locations

1 site across 1 country: United States