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NCT01759394 · ClinicalTrials.gov registry record · Phase 1

A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal

A Phase 1 study of Healthy Volunteers, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT01759394 is a Phase 1 study of Healthy Volunteers that has completed, run by Eisai. The registered enrollment target is 36 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01759394, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Receiving a low-fat Meal.

Conditions Studied

Interventions

  • DRUG Avatrombopag maleate 40 mg

Study Locations (1)

Arizona

  • Celerion - Tempe

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2012-10
Est. Completion 2013-03
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT01759394

The ClinicalTrials.gov registry entry for NCT01759394 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 (93% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Avatrombopag maleate 40 mg is the first listed.

NCT01759394 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT01759394 about?

NCT01759394 is a clinical study titled "A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal". A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Recei...

What is the current status of trial NCT01759394?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-10. Estimated completion is 2013-03.

What conditions does trial NCT01759394 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT01759394?

The interventions under investigation include: Avatrombopag maleate 40 mg (DRUG).

Who is sponsoring clinical trial NCT01759394?

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

Where is trial NCT01759394 being conducted?

This trial has 1 study location across Arizona. 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

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.