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CompletedNCT03142724Updated Mar 6, 2018

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

A Phase 1 interventional study of [18F]MNI-968 in Healthy Volunteers, sponsored by Molecular NeuroImaging. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-06.

Sponsored by Molecular NeuroImaging · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Healthy Volunteers

Keywords

  • HV
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [18F]MNI-968

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

    Drug: [18F]MNI-968

Interventions

  • Drug[18F]MNI-968

    Healthy volunteers recruited for the study will undergo a single \[18F\]MNI-968 injections and PET scans.

    Also known as: PF-06730110

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: 2 Months

06

Study locations

1 site
  • Molecular NeuroImaging, LLC
    New Haven, Connecticut 06510, United States
07

Registry details

Key details

Study ID
NCT03142724
Lead sponsor
Molecular NeuroImaging
Responsible party
Sponsor
First posted
May 5, 2017
Start date
May 1, 2017
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Mar 6, 2018

Study contacts

Jennifer Madonia, PA-C
principal investigator · Molecular NeuroImaging, LLC

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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