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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: Completed Phase 1 study of Healthy Volunteers, sponsored by Green Cross Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The following safety parameters will be recorded at regular intervals during the clinical study\_ * Vital signs (supine blood pressure (BP) and pulse, oral body temperature, respiratory rate (RR)) * Twelve-lead ECG * 24-hour telemetry * Clinical laboratory testing (hematology, clinical chemistry, coagulation and urinalysis) * Hemoccult test * Adverse event assessments * Concomitant medication assessments * Physical examinations
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rivaroxaban
- DRUG GCC-4401C
Study Locations (1)
California
- PAREXEL Internatonal - Early Phase Clinical Unit _Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01954238 record still lists
NCT01954238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01954238's enrollment target sits among peer trials
46 146th of 283 higher than 138 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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