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Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers

This study is not yet open for participant recruitment.
Verified December 2012 by Endocyte
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT01748864
First received: December 10, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Etarfolatide (EC20)
 Phase 1

Study Type: Interventional
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

Further study details as provided by Endocyte:

Primary Outcome Measures:
  • Biodistribution of Radioactive Drug Substance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    To track biodistribution of 99mTc-EC20 injection, blood and urine samples will be collected at set times within the first 24hrs post 99mTc-EC20 injection for all patients and radioactivity measured.

  • Excretion of Radioactive Drug Substance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    To track excretion of 99mTc-EC20 injection, blood and urine samples will be collected at set times within the first 24hrs post 99mTc-EC20 injection for all patients and radioactivity measured.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.



Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm - Healthy Volunteers
Etarfolatide (EC20)
 Drug: Etarfolatide (EC20)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748864

Contacts
Contact: Binh Nguyen, MD, PhD 317-846-1478 ext 1216 bnguyen@endocyte.com

Sponsors and Collaborators
Endocyte
Investigators
Principal Investigator: Wael Harb, MD Horizon Oncology Research, Inc.
  More Information

No publications provided

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01748864     History of Changes
Other Study ID Numbers: EC20.11
Study First Received: December 10, 2012
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endocyte:
Volunteers

ClinicalTrials.gov processed this record on May 21, 2013