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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 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.

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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

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

FieldValue
Enrollment Target 56 participants
Start Date 2013-12
Est. Completion 2014-02
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT02010970

The ClinicalTrials.gov registry entry for NCT02010970 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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