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

Endocyte

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Etarfolatide (EC20)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01748864

EC20.11

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.