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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Cypress, CA, United States

Arms	Assigned Interventions
Experimental: Group 1 AZD3293-itraconazole Subjects from Group 1 will receive a single dose of AZD3293 as an oral solution on Day 1 . In Group 1, itraconazole will be administered orally twice daily starting on Day 5 for 9 consecutive days (Days 5 to 13). On Day 8, a single dose of AZD3293 will be coadministered as an oral solution after the morning dose of itraconazole. Group 1 subjects will be discharged on Day 14.	Drug: Group 1 AZD3293 AZD3293 oral solution Other Name: beta secretase inhibitor Drug: Group 1 Itraconazole itraconazole capsule Other Name: azole antifungal
Experimental: Group 2 AZD3293-diltiazem Subjects from Group 2 will receive a single dose of AZD3293 as an oral solution on Day 1 . In Group 2, diltiazem will be administered orally once daily starting on Day 5, for 9 consecutive days (Days 5 to 13). On Day 8, a single dose of AZD3293 will be coadministered as an oral solution after the diltiazem dose. Group 2 subjects will be discharged on Day 14.	Drug: Group 2 AZD3293 AZD3293 oral solution Other Name: beta secretase inhibitor Drug: Group 2 Diltiazem Diltiazem ER tablet Other Name: calcium channel blocker
Experimental: Group 3 AZD3293-midazolam Subjects from Group 3 will receive a single dose of midazolam on Day 1 . AZD3293 will be administered as an oral solution once daily starting on Day 2 for 9 consecutive days (Days 2 to 10) followed by a 7 day wash-out period. On Day 8 and Day 17 a single dose of midazolam will be administered. Group 3 subjects will be discharged on Day 18	Drug: Group 3 AZD3293 AZD3293 oral solution Other Name: beta secretase inhibitor Drug: Group 3 Midazolam midazolam syrup Other Name: benzodiazepine

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Robert Alexander

ClinicalTrialTransparency@astrazeneca.com

Contact Backup

Apinya Vutikullird

(714) 252-0700

Investigators

Principal Investigator