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Completed

NCT Number: NCT01748864

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MD Clinical, Hallendale, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etarfolatide (EC20)

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Endocyte

Industry

Registry information

Official study title

A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2012
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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