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NCT01525394 · ClinicalTrials.gov registry record · Phase 1

A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval

A Phase 1 study, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT01525394 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 52 participants.

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The verdict

NCT01525394, a Phase 1 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion of study termination procedures will be performed at Visit 11.

Interventions

  • DRUG Lenvatinib
  • DRUG Moxifloxacin 400 mg
  • DRUG Placebos (matched to 4 mg and 10 mg lenvatinib capsules).

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2010-12
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT01525394

The ClinicalTrials.gov registry entry for NCT01525394 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Lenvatinib is the first listed.

NCT01525394 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01525394 about?

NCT01525394 is a clinical study titled "A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval". This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomi...

What is the current status of trial NCT01525394?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-12.

What interventions are being tested in trial NCT01525394?

The interventions under investigation include: Lenvatinib (DRUG), Moxifloxacin 400 mg (DRUG), Placebos (matched to 4 mg and 10 mg lenvatinib capsules). (DRUG).

Who is sponsoring clinical trial NCT01525394?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

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.