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NCT02010970 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Healthy Volunteers and Pharmacologic Action, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT02010970: Completed Phase 1 study of Healthy Volunteers and Pharmacologic Action, sponsored by AstraZeneca.
NCT02010970 is a Phase 1 study of Healthy Volunteers and Pharmacologic Action that has completed, run by AstraZeneca. The registered enrollment target is 56 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02010970, a Phase 1 study of Healthy Volunteers and Pharmacologic Action, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Group 1 AZD3293
- DRUG Group 2 AZD3293
- DRUG Group 3 AZD3293
- DRUG Group 1 Itraconazole
- DRUG Group 2 Diltiazem
Study Locations (1)
California
- Research Site - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT02010970 record still lists
NCT02010970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Group 1 AZD3293 is the first listed.
NCT02010970 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02010970 about?
NCT02010970 is a clinical study titled "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". 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-d...
What is the current status of trial NCT02010970?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2013-12. Estimated completion is 2014-02.
What conditions does trial NCT02010970 study?
This clinical trial studies the following conditions: Healthy Volunteers, Pharmacologic Action.
What interventions are being tested in trial NCT02010970?
The interventions under investigation include: Group 1 AZD3293 (DRUG), Group 2 AZD3293 (DRUG), Group 3 AZD3293 (DRUG), Group 1 Itraconazole (DRUG), Group 2 Diltiazem (DRUG).
Who is sponsoring clinical trial NCT02010970?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02010970 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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56 129th of 283 higher than 152 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
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