Intervention: Tetrafluoroborate
Trial phase: Phase 1 | Phase 2
SMILES: F[B-](F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.

BF4: Single IV dose of 9-11 mCi sodium [Fluorine-18] radiolabeled B4^F
Eligibility criteria:
Inclusion Criteria:

Four male and four female healthy volunteers, greater than 21 years of age.
Subjects must provide written informed consent.
Willingness to provide all biological specimens as required by the protocol

Exclusion Criteria:

Volunteers with any of the following are ineligible to enroll in this study:

Have currently clinically significant cancer, neurologic, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, especially thyroid disease;

Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:

cardiac surgery or myocardial infarction within the last 6 months;
unstable angina;
coronary artery disease that required a change in medication within the last 3 months;
decompensated congestive heart failure;
significant cardiac arrhythmia or conduction disturbance, particularly those resulting in atrial or ventricular fibrillation, or causing syncope, near syncope, or other alterations in mental status;
severe mitral or aortic valvular disease;
uncontrolled high blood pressure;
congenital heart disease;
History of drug or alcohol abuse within the last year, or prior prolonged history of abuse;
Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;
Women of childbearing potential must not be pregnant (negative urine Human Chorionic Gonadotropin (β-HCG) at the time of screen) or lactating over the course of the study. A commercial urine dipstick test will be performed within 48 hours prior to injection of [18F]BF4 unless the screening urine pregnancy test falls within 48 hours of injection.
Volunteers who, in the opinion of the investigator, are otherwise unsuitable for a study of this type;
History of severe drug allergy or hypersensitivity; or
Volunteers who had received an investigational medication within the last 30 days or who have participated in a clinical trial with any experimental medication or radiopharmaceutical in the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication.
Volunteers who are taking drugs with narrow therapeutic windows, such as theophylline, or warfarin, heparin and other anticoagulant therapies