Healthy
Conditions
Keywords
Volunteers
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.
Interventions
DRUGEtarfolatide (EC20)
Sponsors
Endocyte
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Radioactive Drug Substance | 24 hours | To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of SPECT images of Normal Volunteers with or without injection of Folic Acid | 24 hours | Comparison made of SPECT images taken of volunteers who received folic acid injection prior to 99mTc-EC20 injection and those who did not receive folic acid injection. Readability of scans, background noise as well as evaluation of any other differences will be noted. |
Countries
United States
Outcome results
None listed