drugset / Trial / 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
Non-randomizedParallel-groupOpen-labelBasic science
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
Timeline
- Start
- 2013-12
- Primary completion
- 2014-02
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diltiazem | Small molecule | — | Oral |
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Lanabecestat | Small molecule | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
Indications
No indication recorded.