The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane
I 123 in normal human volunteers.
Drug: no carrier added metaiodobenzylguanidine
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Locations near you
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Full eligibility criteria for NCT01730417
Ages eligible for Study
21 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
normal healthy volunteers with written informed consent who understand and are willing to comply with protocol requirements
at least 21 years of age
if female, then not of childbearing potential as documented by history (e.g., tubal ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses
if female of childbearing potential, a negative serum beta HCG pregnancy test within 24 hours prior to receiving iobenguane I 123
if female of childbearing potential, agrees to use an acceptable form of birth control, defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant, throughout the study period
No existing predisposition to administration of thyroid blocking potassium iodide
females who are nursing
documented history of significant allergy that required medical intervention to shellfish, X-ray contrast media, iodine/iodides, or iobenguane
administered a radioisotope within 5 effective half-lives of that radioisotope prior to study enrollment
abnormal screening laboratory studies (serum creatinine, SPOT, SGPT, total bilirubin as defined by standard laboratory reference ranges)
those who have received an investigational compound and/or medical device within 30 days of entering this study
pre-existing medical condition or circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study, (e.g. cancer, heart disease, or other medical conditions which potentially alter normal biodistribution)
is determined by the investigator that the patient is clinically unsuitable for the study
are taking medication which inhibits uptake of iobenguane I 123 within 2 weeks of enrollment, or tricyclic antidepressants or related drugs within 6 weeks of enrollment. Categories of medications include sympathomimetics, antihypertensives and cardiovascular agents, opioids, antipsychotics, tricyclic antidepressants, and medications as previously published
have participated in a clinical trial with an investigational drug in the past 30 days.
All locations for NCT01730417
United States (1)
Duke University Medical Center
Durham, North Carolina, United States, 27710
View full eligibility
Tris trial is registered with FDA with number: NCT01730417. The sponsor of the trial is Bennett Chin and it is looking for 12 volunteers for the current phase.
Official trial title: Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG-Nanodosing: the Path to Higher Sensitivity and Lower Toxicity Radiopharmaceuticals
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