NCT03142724

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2017

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

May 2, 2017

Last Update Submit

March 5, 2018

Conditions

Healthy Volunteers

Keywords

HV

Outcome Measures

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.

    2 Months

Study Arms (1)

[18F]MNI-968

EXPERIMENTAL

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

Drug: [18F]MNI-968

Interventions

[18F]MNI-968DRUG

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

Also known as: PF-06730110
[18F]MNI-968

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related Links

Study Officials

  • Jennifer Madonia, PA-C

    Molecular NeuroImaging, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 5, 2017

Study Start

May 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

US(1)