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NCT02039076 · ClinicalTrials.gov registry record · Phase 1

A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects

A Phase 1 study of Thrombocytopenia, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
1
Study location

NCT02039076 is a Phase 1 study of Thrombocytopenia that has completed, run by Eisai. The registered enrollment target is 48 participants, below the 310-participant average among 20 other Thrombocytopenia trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02039076, a Phase 1 study of Thrombocytopenia, has completed, sponsored by Eisai.

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

Study Summary

This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will be used to assess the fed condition.

Conditions Studied

Interventions

  • DRUG avatrombopag

Study Locations (1)

California

  • Parexel International Early Development Clinical Units - Glendale

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2013-12
Est. Completion 2014-09
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT02039076

The ClinicalTrials.gov registry entry for NCT02039076 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 310-participant average among 20 other Thrombocytopenia trials with a reported enrollment target (85% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Thrombocytopenia appearing as the primary indexed condition, and to 1 intervention - of which avatrombopag is the first listed.

NCT02039076 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT02039076 about?

NCT02039076 is a clinical study titled "A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects". This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will ...

What is the current status of trial NCT02039076?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-12. Estimated completion is 2014-09.

What conditions does trial NCT02039076 study?

This clinical trial studies the following conditions: Thrombocytopenia.

What interventions are being tested in trial NCT02039076?

The interventions under investigation include: avatrombopag (DRUG).

Who is sponsoring clinical trial NCT02039076?

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

Where is trial NCT02039076 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

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.