A Phase 1 interventional study of Group 1 AZD3293 and Group 2 AZD3293 in Healthy Volunteers and Pharmacologic Action, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-28.
Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science
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
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Exclusion Criteria:
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 · Drug: Group 1 Itraconazole
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 · Drug: Group 2 Diltiazem
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 · Drug: Group 3 Midazolam
AZD3293 oral solution
Also known as: beta secretase inhibitor
AZD3293 oral solution
Also known as: beta secretase inhibitor
AZD3293 oral solution
Also known as: beta secretase inhibitor
itraconazole capsule
Also known as: azole antifungal
Diltiazem ER tablet
Also known as: calcium channel blocker
midazolam syrup
Also known as: benzodiazepine
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
In Group 1, serial blood samples for AZD3293 plasma concentrations will be collected from predose to 96 hours after administration of AZD3293 on Day 1 and from predose to 144 hours after study drug administration on Day 8. Sparse blood samples for itraconazole plasma concentrations will be collected at predose (prior to administration of AZD3293) on Day 1 and 2 hours after the morning dose of itraconazole on Day 5 through Day 13. In Group 2, serial blood samples for AZD3293 plasma concentrations will be collected from predose to 96 hours after administration of AZD3293 on Day 1 and from predose to 144 hours after study drug administration on Day 8. Sparse blood samples for diltiazem plasma concentrations will be collected at predose (prior to administration of AZD3293) on Day 1 and 3 hours after diltiazem administration on Day 5 through Day 13.
Time frame: up to day 13
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
Serial blood samples for midazolam plasma concentrations will be collected from predose to 24 hours after administration of midazolam on Day 1 and Day 17 and for 48 hours after administration of midazolam on Day 8. Sparse blood samples for AZD3293 plasma concentrations will be collected at predose (prior to administration of midazolam) on Day 1 and 2 hours after AZD3293 administration on Day 2 through Day 10.
Time frame: up to day 17
Safety profile in terms of Adverse events assessment
Time frame: from Baseline and up to day 18
Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)
Time frame: from Baseline and up to day 18
Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams
Time frame: from baseline and up till day 18
Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters
Time frame: from Baseline and up to day 18
Safety and tolerability by assessing telemetry records
Time frame: from baseline and up to day 13
Suicidality mesured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: from Baseline and up till day 18
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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