Assessment of the Biodistribution and Safety of [18F]MNI-958 in Healthy Subjects

The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-958 also known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [18F]MNI-958

Detailed Description

The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-958 also known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical. The specific objectives are:

• To determine the radiation dosimetry of [18F]MNI-958
• To assess the safety and tolerability of a single dose of [18F]MNI-958

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental: [18F]MNI-958; To assess the safety and tolerability and to determine the radiation dosimetry of [18F]MNI-958.	Drug: [18F]MNI-958; Healthy Volunteers recruited for the study will undergo a single [18F]MNI-958 injection and PET scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Biodistribution and Safety of [18F]MNI-958 in Healthy Subjects	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

Collaborators and Investigators

• Sponsor: Invicro

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2017
• Primary Completion (ACTUAL): April 20, 2018
• Study Completion (ACTUAL): April 20, 2018

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (ACTUAL): March 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: HV
• Other Study ID Numbers: [18F]MNI-958 Dosimetry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No