NCT01748864

CompletedPhase 1

Evaluation of the Biodistribution and Safety of 99mTC-Etarfo...

Endocyte Source

Compare

Other study identifiers

Sponsor study identifier

EC20.11

Study Type

interventional

Actual enrollment (reported)

23

Locations

1 country

Sites

2

Timeline

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2013

Actual (reported)

Study Completion

October 2013

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 23 participants
Study completion date: October 2013
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 10, 2012
Actual (reported)
First Posted
December 13, 2012
Actual (reported)
Study Start
April 2013
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)
Study Completion
October 2013
Actual (reported)

Last Updated: July 29, 2014
Status Verified: July 2014
Last Update Submitted: July 28, 2014

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Endocyte
Industrylead

Study Sites (2)

MD Clinical

Hallendale, Florida, United States

Horizon Oncology

Lafayette, Indiana, United States

Study Officials

Wael Harb, MD
Horizon Oncology Research, Inc.
PRINCIPAL INVESTIGATOR
Beth Safirstein, MD
MD Clinical
PRINCIPAL INVESTIGATOR

Enrollment

23 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT01844804

A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)

Phase 1Completed

NCT01858935

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy Subjects

Phase 1Completed

NCT01756781

A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.

Phase 1Completed

NCT01821066

A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers

Phase 1Completed

NCT01911637

Safety Study of Single Oral Doses of VBY-036 in Healthy Volunteers (VBY036P1A)

Phase 1Completed

NCT01826786

The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers

Phase 1Completed

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.

Contact the study team to confirm eligibility.

Primary Completion

October 2013

Actual (reported)

Study Completion

October 2013

Actual (reported)

Last Updated

July 29, 2014

Record last verified: 2014-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01748864
Data provider: ClinicalTrials.gov
Source updated: 2014-07-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:16 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (1)

Single Arm - Healthy Volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations