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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Etarfolatide (EC20)

• Registration Number: NCT01748864
• Lead Sponsor: Endocyte

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Study Start: 2013-04
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm - Healthy Volunteers	Etarfolatide (EC20)	Etarfolatide (EC20)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

MD Clinical; 🇺🇸 Hallendale, Florida, United States

Horizon Oncology; 🇺🇸 Lafayette, Indiana, United States