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

NCT01748864 | Completed Phase 1

• 1 other identifier: EC20.11
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

• Distribution of Radioactive Drug Substance

  To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.

  24 hours

Secondary Outcomes (2)

• Safety of 99mTc-Etarfolatide in Normal Volunteers

  4 days post-injection of EC20

• Tolerability of 99mTc-Etarfolatide in Normal Volunteers

  4 days

Other Outcomes (1)

• Quality of SPECT images of Normal Volunteers with or without injection of Folic Acid

  24 hours

Study Arms (1)

Single Arm - Healthy Volunteers

EXPERIMENTAL

Etarfolatide (EC20)

Drug: Etarfolatide (EC20)

Interventions

Etarfolatide (EC20) DRUG

Single Arm - Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endocyte: lead

Study Sites (2)

MD Clinical

Hallendale, Florida, United States

Location

Horizon Oncology

Lafayette, Indiana, United States

Location

Study Officials

• Wael Harb, MD

  Horizon Oncology Research, Inc.

  PRINCIPAL INVESTIGATOR

• Beth Safirstein, MD

  MD Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 13, 2012
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

US (2)