Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01748864|
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : July 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Etarfolatide (EC20)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Single Arm - Healthy Volunteers
Drug: Etarfolatide (EC20)
- Distribution of Radioactive Drug Substance [ Time Frame: 24 hours ]To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.
- Safety of 99mTc-Etarfolatide in Normal Volunteers [ Time Frame: 4 days post-injection of EC20 ]Asses any adverse events and serious adverse events experienced by volunteers.
- Tolerability of 99mTc-Etarfolatide in Normal Volunteers [ Time Frame: 4 days ]Asses any adverse events and serious adverse events experienced by volunteers.
- Quality of SPECT images of Normal Volunteers with or without injection of Folic Acid [ Time Frame: 24 hours ]
Comparison made of SPECT images taken of volunteers who received folic acid injection prior to 99mTc-EC20 injection and those who did not receive folic acid injection.
Readability of scans, background "noise" as well as evaluation of any other differences will be noted.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748864
|United States, Florida|
|Hallendale, Florida, United States|
|United States, Indiana|
|Lafayette, Indiana, United States|
|Principal Investigator:||Wael Harb, MD||Horizon Oncology Research, Inc.|
|Principal Investigator:||Beth Safirstein, MD||MD Clinical|