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Also known as beta secretase inhibitor
Group 1 AZD3293 · 1 trial · 2 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| Group 1 AZD3293-itraconazole | EXPERIMENTAL | 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. |
| Group 2 AZD3293-diltiazem | EXPERIMENTAL | 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. |
| Group 3 AZD3293-midazolam | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| Group 1 AZD3293 | DRUG | AZD3293 oral solution |
| Group 2 AZD3293 | DRUG | AZD3293 oral solution |
| Group 3 AZD3293 | DRUG | AZD3293 oral solution |
| Group 1 Itraconazole | DRUG | itraconazole capsule |
| Group 2 Diltiazem | DRUG | Diltiazem ER tablet |
| Group 3 Midazolam | DRUG | midazolam syrup |
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 f...
Group 1 AZD3293 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in a Phase 1 clinical trial in healthy volunteers to assess drug interactions involving cytochrome P450 enzymes. The specific therapeutic indication for Group 1 AZD3293 has not been disclosed.
Group 1 AZD3293 is being developed by AstraZeneca PLC, which trades under the ticker symbol AZN. AstraZeneca is the sponsor of the clinical program for this investigational small molecule.
Group 1 AZD3293 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
Group 1 AZD3293 has been evaluated in one completed Phase 1 trial, NCT02010970. This study enrolled 56 healthy volunteers in the United States to assess the effect of CYP3A4 inhibitors diltiazem and itraconazole on the pharmacokinetics of AZD3293, and the effect of AZD3293 on midazolam pharmacokinetics.
Group 1 AZD3293 is a small molecule, but its molecular target and mechanism of action have not been disclosed. The completed Phase 1 trial focused on drug-drug interactions involving cytochrome P450 enzymes, specifically CYP3A4 and CYP3A5, rather than on a therapeutic mechanism.