A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807

NCT01733355 | Terminated Early Phase 1

• 1 other identifier: T807000
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

\[F-18\]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.

Conditions

Alzheimers Disease; AD

Outcome Measures

Primary Outcomes (4)

• To evaluate the bio-distribution and radiation dosimetry of [F-18]T807 in participants with low probability of Alzheimer's disease (AD) using PET/CT whole body imaging

  up to 15 days per patient

• To evaluate the metabolism of [F-18]T807 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration

  up to 15 days per patient

• To evaluate [F-18]T807 uptake and signal/background information in brain PET/CT imaging of participants with a high probability of currently being positive for AD and age-matched participants with a low probability of currently being positive for AD

  upto 15 days per patient

• To assess the safety of IV administration of [F-18]T807

  Safety will be monitored for all subjects by the: * Number of subjects experiencing adverse events from baseline to 24 hours post-administration. * Number and type of adverse events. * Changes in clinical laboratory assessments (CBC and clinical chemistry)from baseline to 24 hours post administration. * Changes in physical examination from baseline to 24 hours post administration. * Changes in vital sign measurements (systolic blood pressure \[mmHg\]; diastolic blood pressure \[mmHg\], pulse rate \[bpm\] and body temperature) from baseline prior to \[F-18\]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration)and at 24 hours post administration. * Changes in ECG measurements, from baseline prior to \[F-18\]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration) and at 24 hours post administration.

  up to 24 hours post [F18]T807 administration

Secondary Outcomes (2)

• To begin collection of baseline [F-18]T807 PET/CT imaging data

  up to 15 days per patient

• To gain information to improve the study design for the conduct of future trials

  up to 15 days per patient

Study Arms (1)

Tau diagnostic

EXPERIMENTAL

\[F18\] T807

Radiation: [F18] T807

Interventions

[F18] T807 RADIATION

Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi

Also known as: Tau [F-18]T807

Tau diagnostic

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has reached his or her 55th birthday at the time of informed consent (Participant is male or female of any race / ethnicity)
• Participant provides written informed consent
• Participant is capable of complying with study procedures
• Participant is capable of communicating with study personnel
• Participant understands and speaks English
• Participant has at least an 8th Grade education
• In the Investigator's opinion, participant has a low probability of being currently positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined in APPENDIX VI of protocol T807000, IND 114102
• Participant has no significant hepatic or renal disease as defined by previous medical history and lab results are within the following ranges:
• Total bilirubin within 2x institutional upper limits of normal
• AST (SGOT) ≤ 2.5 x institutional upper limits of normal
• ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
• Creatinine ≤ 2x institutional upper limits of normal
• BUN within 2x institutional upper limits of normal
• High Probability for AD Participants (Group 2)
• Participant has reached his or her 55th birthday at the time of informed consent (Participant is male or female of any race / ethnicity)

You may not qualify if:

• Female participant is pregnant or nursing
• Participant has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
• Participant has other neurodegenerative disease that is associated with cognitive impairment or dementia
• Participant has a medical condition that might be associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
• Participant has a history of significant cerebrovascular disease
• Participant has previously received \[F-18\]T807 at any time
• Participant has been involved in an investigative, radioactive research procedure within the past 14 days
• Participant has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality
• Participant has a history in the last five years of significant prescription or non-prescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (2)

Research Site

Irvine, California, 92697, United States

Location

Research Site

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; tau Proteins

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Microtubule-Associated Proteins; Microtubule Proteins; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: November 27, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

US (2)