Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in normal volunteers. Study will determine biodistribution and excretion of the radioactive drug substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal volunteers.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers|
- Distribution of Radioactive Drug Substance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Asses any adverse events and serious adverse events experienced by volunteers.
- Tolerability of 99mTc-Etarfolatide in Normal Volunteers [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||April 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Single Arm - Healthy Volunteers
|Drug: Etarfolatide (EC20)|
Please refer to this study by its ClinicalTrials.gov identifier: 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|