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NCT01954238 · ClinicalTrials.gov registry record · Phase 1

A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers

A Phase 1 study of Healthy Volunteers, sponsored by Green Cross Corporation.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
1
Study location

NCT01954238 is a Phase 1 study of Healthy Volunteers that has completed, run by Green Cross Corporation. The registered enrollment target is 46 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01954238, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Green Cross Corporation.

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

Study Summary

The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Rivaroxaban
  • DRUG GCC-4401C

Study Locations (1)

California

  • PAREXEL Internatonal - Early Phase Clinical Unit _Los Angeles

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2013-08
Est. Completion 2014-05
Phase Phase 1

Sponsor

Green Cross Corporation

4 total trials

What the Registry Record Tells You About NCT01954238

The ClinicalTrials.gov registry entry for NCT01954238 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 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 (90% lower). The listed sponsor is Green Cross Corporation, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01954238 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01954238 about?

NCT01954238 is a clinical study titled "A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers". The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.

What is the current status of trial NCT01954238?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-08. Estimated completion is 2014-05.

What conditions does trial NCT01954238 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT01954238?

The interventions under investigation include: Placebo (DRUG), Rivaroxaban (DRUG), GCC-4401C (DRUG).

Who is sponsoring clinical trial NCT01954238?

This trial is sponsored by Green Cross Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01954238 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.