Assessment of the Biodistribution and Safety of [18F]MNI-968 in Healthy Subjects

Sponsor
Molecular NeuroImaging (Other)
Overall Status
Completed
CT.gov ID
NCT03142724
Collaborator
(none)
6
1
1
10
0.6

Study Details

Study Description

Brief Summary

The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical. The specific objectives are:

  • To determine the radiation dosimetry of [18F]MNI-968

  • To assess the safety and tolerability of a single dose of [18F]MNI-968

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of the Biodistribution and Safety of [18F]MNI-968 (Aka PF-06730110) in Healthy Subjects
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: [18F]MNI-968

To assess the safety and tolerability and to determine the radiation dosimetry of [18F]MNI-968.

Drug: [18F]MNI-968
Healthy volunteers recruited for the study will undergo a single [18F]MNI-968 injections and PET scans.
Other Names:
  • PF-06730110
  • Outcome Measures

    Primary Outcome Measures

    1. Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity. [2 Months]

      Volumes of interest (VOI) will be placed on the visually identified source organs, and subsequently used for all the study PET frames. Activity within these volumes of interest is expressed in units of total radioactivity (kBq). Radioactivity will be corrected for body attenuation, but not for decay, and time activity data (TAC) generated for each source organ.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    • The participant is 18 to 55 years old.

    • Written informed consent must be obtained before any assessment is performed.

    • Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.

    • Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.

    • Male subjects must not donate sperm for the study duration.

    • Willing and able to cooperate with study procedures

    Exclusion Criteria

    • The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.

    • The subject is a currently exposed to nicotine products or had regular nicotine exposure within a six month period, to be verified by urine cotinine screening.

    • History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening visit.

    • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

    • The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.

    • Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure does not exceed the effective dose of 50 mSv, equivalent with the acceptable annual limits established by the US Federal Guidelines.

    • Pregnancy or women who are breastfeeding, lactating or nursing.

    • Unsuitable veins for repeated venipuncture.

    • History of immunodeficiency diseases, including a positive HIV test result

    • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Molecular NeuroImaging, LLC New Haven Connecticut United States 06510

    Sponsors and Collaborators

    • Molecular NeuroImaging

    Investigators

    • Principal Investigator: Jennifer Madonia, PA-C, Molecular NeuroImaging, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Molecular NeuroImaging
    ClinicalTrials.gov Identifier:
    NCT03142724
    Other Study ID Numbers:
    • [18F]MNI-968 Dosimetry
    First Posted:
    May 5, 2017
    Last Update Posted:
    Mar 6, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Molecular NeuroImaging

    Study Results

    No Results Posted as of Mar 6, 2018