HealthyPhase 1NCT01748864
Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
A Phase 1 study testing Etarfolatide (EC20) in people with Healthy, run by Endocyte at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Etarfolatide (EC20)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Clinical
Hallendale, Florida
Horizon Oncology
Lafayette, Indiana
About this study
Official title: A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
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
- Being tested
- Etarfolatide (EC20)
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etarfolatide (EC20)Drug
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Healthy Volunteers | Experimental | Etarfolatide (EC20) Receives: Drug: Etarfolatide (EC20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Radioactive Drug Substance
To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.
Measured: 24 hours
Secondary outcomes (2)
Safety of 99mTc-Etarfolatide in Normal Volunteers
Asses any adverse events and serious adverse events experienced by volunteers.
Measured: 4 days post-injection of EC20
Tolerability of 99mTc-Etarfolatide in Normal Volunteers
Asses any adverse events and serious adverse events experienced by volunteers.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wael Harb, MD, Principal investigator, Horizon Oncology Research, Inc.Beth Safirstein, MD, Principal investigator, MD Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748864
- Sponsor's protocol ID
- EC20.11
- Status last verified
- Jul 2014
- First submitted
- 10 Dec 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
- ClinicalTrials.gov ID
- NCT01748864
- Acronym / sponsor ID
- EC20.11
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Healthy Volunteers | Experimental | Drug: Etarfolatide (EC20)Etarfolatide (EC20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etarfolatide (EC20) | Drug | Single Arm - Healthy Volunteers |
Primary outcome
Distribution of Radioactive Drug Substance
Time frame: 24 hours
To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.
2 secondary outcomes
Safety of 99mTc-Etarfolatide in Normal Volunteers
Time frame: 4 days post-injection of EC20
Tolerability of 99mTc-Etarfolatide in Normal Volunteers
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Harb, MD principal investigator
Horizon Oncology Research, Inc.
Beth Safirstein, MD principal investigator
MD Clinical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etarfolatide (EC20) in people with Healthy, run by Endocyte at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Radioactive Drug Substance (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.