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NCT01772290 · ClinicalTrials.gov registry record · Phase 1

A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib

A Phase 1 study of Healthy Volunteer, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
92
Enrollment target
2
Study locations

NCT01772290 is a Phase 1 study of Healthy Volunteer that has completed, run by Genentech. The registered enrollment target is 92 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01772290, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
92 participants
Enrollment target
2
Study locations

Study Summary

This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subjects will be randomized to receive multiple oral doses of vismodegib, alone or in combination with multiple oral doses of either rabeprazole, itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.

Conditions Studied

Interventions

  • DRUG itraconazole
  • DRUG fluconazole
  • DRUG rabeprazole
  • DRUG vismodegib

Study Locations (2)

Florida

  • - Daytona Beach

Texas

  • - Dallas

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2013-02
Est. Completion 2013-05
Phase Phase 1

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01772290

The ClinicalTrials.gov registry entry for NCT01772290 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (54% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which itraconazole is the first listed.

NCT01772290 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT01772290 about?

NCT01772290 is a clinical study titled "A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib". This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subje...

What is the current status of trial NCT01772290?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2013-02. Estimated completion is 2013-05.

What conditions does trial NCT01772290 study?

This clinical trial studies the following conditions: Healthy Volunteer.

What interventions are being tested in trial NCT01772290?

The interventions under investigation include: itraconazole (DRUG), fluconazole (DRUG), rabeprazole (DRUG), vismodegib (DRUG).

Who is sponsoring clinical trial NCT01772290?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01772290 being conducted?

This trial has 2 study locations across Florida, Texas. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.