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

A Single-Center Phase I Clinical Study to Evaluate 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Etarfolatide (EC20)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hallendale, Florida, United States
      • MD Clinical
  • Indiana
    • Lafayette, Indiana, United States
      • Horizon Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm - Healthy Volunteers; Etarfolatide (EC20)	Drug: Etarfolatide (EC20)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Radioactive Drug Substance	To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of 99mTc-Etarfolatide in Normal Volunteers	Asses any adverse events and serious adverse events experienced by volunteers.	4 days post-injection of EC20
Tolerability of 99mTc-Etarfolatide in Normal Volunteers	Asses any adverse events and serious adverse events experienced by volunteers.	4 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of SPECT images of Normal Volunteers with or without injection of Folic Acid	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.	24 hours

Collaborators and Investigators

• Sponsor: Endocyte
• Investigators: Principal Investigator: Wael Harb, MD, Horizon Oncology Research, Inc.; Principal Investigator: Beth Safirstein, MD, MD Clinical

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Volunteers
• Other Study ID Numbers: EC20.11