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
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No locations available
| 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 |
Investigators
Principal Investigator
Apinya Vutikullird
WCCT Global
