Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT01748864
First received: December 10, 2012
Last updated: July 28, 2014
Last verified: July 2014
  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:
  • 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.


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.



Enrollment: 23
Study Start Date: April 2013
Study Completion Date: October 2013
Primary Completion Date: October 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
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, see Learn About Clinical Studies.

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

Locations
United States, Florida
MD Clinical
Hallendale, Florida, United States
United States, Indiana
Horizon Oncology
Lafayette, Indiana, United States
Sponsors and Collaborators
Endocyte
Investigators
Principal Investigator: Wael Harb, MD Horizon Oncology Research, Inc.
Principal Investigator: Beth Safirstein, MD MD Clinical
  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: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Endocyte:
Volunteers

ClinicalTrials.gov processed this record on November 25, 2014