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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers; Pharmacologic Action

Intervention: Group 1 AZD3293 (Drug); Group 2 AZD3293 (Drug); Group 3 AZD3293 (Drug); Group 1 Itraconazole (Drug); Group 2 Diltiazem (Drug); Group 3 Midazolam (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Apinya Vutikullird, DO, Principal Investigator, Affiliation: WCCT Global


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

Clinical Details

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

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

Primary outcome:

The effect of multiple-dose co-administration of CYP3A4 inhibitors on the single-dose PK of AZD3293 measured by assessment of area under the curve over the time (AUC) and maximum concentration

The effect of multiple-dose AZD3293 administration (including the reversibilityof any of its effects) on the single-dose PK of a CYP3A4/CYP3A5 substrate (midazolam) by assessment of area under the curve over the time (AUC) and maximum concentration

Secondary outcome:

Safety profile in terms of Adverse events assessment

Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)

Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams

Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters

Safety and tolerability by assessing telemetry records

Suicidality mesured by Columbia-Suicide Severity Rating Scale (C-SSRS)


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Provision of signed, written, and dated informed consent prior to any study-specific

procedures Male and nonfertile female healthy subjects, aged 18 to 55 years at the time of consent

- Body weight ≥50 to ≤100 kg and body mass index (BMI) ≥19 to ≤30 kg/m2

- Clinically normal findings on physical examination in relation to age, as judged by

the Investigator

- Male healthy subjects must be willing to use barrier contraception, ie, condoms, even

if their partners are post-menopausal, surgically sterile, or using accepted contraceptive methods, from the first day of dosing until 3 months after the last dose of investigational product (IP) Exclusion Criteria:

- Participation in any prior study of AZD3293

- History of any clinically significant disease or disorder which, in the opinion of

the Investigator, may put the subject at risk because of participation in the study, may influence the results, or may limit the subject's ability to participate in the study

- History or presence of gastrointestinal, hepatic or renal disease or any other

condition known to interfere with absorption, distribution, metabolism or excretion of drugs

- History of previous or ongoing psychiatric disease/condition including psychosis,

affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), as assessed by the Mini-International Neuropsychiatric Interview (MINI)

Locations and Contacts

Research Site, Cypress, California, United States
Additional Information

Starting date: December 2013
Last updated: April 25, 2014

Page last updated: August 23, 2015

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