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 - AZD3293DDI

Study identifier:D5010C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy Volunteers, Pharmacologic action

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Group 1 AZD3293, Group 2 AZD3293, Group 3 AZD3293, Group 1 Itraconazole, Group 2 Diltiazem, Group 3 Midazolam

Sex

All

Actual Enrollment

56

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Dec 2013
Primary Completion Date: 01 Feb 2014
Study Completion Date: 01 Feb 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Apr 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria