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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. Identifier: NCT01748864
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Etarfolatide (EC20) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Single Arm - Healthy Volunteers
Etarfolatide (EC20)
Drug: Etarfolatide (EC20)

Primary Outcome Measures :
  1. Distribution of Radioactive Drug Substance [ Time Frame: 24 hours ]
    To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.

Secondary Outcome Measures :
  1. 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.

  2. Tolerability of 99mTc-Etarfolatide in Normal Volunteers [ Time Frame: 4 days ]
    Asses any adverse events and serious adverse events experienced by volunteers.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01748864

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United States, Florida
MD Clinical
Hallendale, Florida, United States
United States, Indiana
Horizon Oncology
Lafayette, Indiana, United States
Sponsors and Collaborators
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Principal Investigator: Wael Harb, MD Horizon Oncology Research, Inc.
Principal Investigator: Beth Safirstein, MD MD Clinical

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Responsible Party: Endocyte Identifier: NCT01748864    
Other Study ID Numbers: EC20.11
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Endocyte: