Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bennett Chin
• Collaborators: Molecular Insights Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: 3-Iodobenzylguanidine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.