Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01748864
- Run by
- Endocyte
- People needed
- 23
- Starts
- 2013-04-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2014-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject must be 18 years of age or older.
- Subject must not have any major health problems as deemed by principal investigator.
- Subject must provide informed consent prior to enrollment.
You may not qualify if…
- Subject is pregnant or breast-feeding.
- Subject is simultaneously participating in another investigative drug or device study.
- Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study.
- Subject has a known history of chronic abuse of drugs or alcohol or tests positive in pre-study urine drug abuse screen.
- Subject is currently taking folic acid supplements and cannot stop taking the supplements for a period of 8 days (7 days prior to the study and one day after last imaging procedure).
- Subject's physical condition unsuitable for radionuclide imaging.
- Subject has been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of 99mTc-etarfolatide.
Where it is running
- MD Clinical — Hallendale, Florida, United States
- Horizon Oncology — Lafayette, Indiana, United States
Full record on ClinicalTrials.gov
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