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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm - Healthy Volunteers

Etarfolatide (EC20)

Group Type EXPERIMENTAL

Etarfolatide (EC20)

Intervention Type DRUG

Interventions

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Etarfolatide (EC20)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes