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

• Sponsor: Invicro (Other)
• Overall Status: Completed
• CT.gov ID: NCT03472313
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [18F]MNI-958	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 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-958 in Healthy Subjects
• Actual Study Start Date: Nov 14, 2017
• Actual Primary Completion Date: Apr 20, 2018
• Actual Study Completion Date: Apr 20, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Assessment of the Biodistribution and Safety of [18F]MNI-958 in Healthy Subjects [2 months]

   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.

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	Invicro	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Invicro

Investigators

• Principal Investigator: Jennifer Madonia, PA-C, Invicro

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Invicro
• ClinicalTrials.gov Identifier: NCT03472313
• Other Study ID Numbers: [18F]MNI-958 Dosimetry
• First Posted: Mar 21, 2018
• Last Update Posted: Oct 22, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Invicro: HV

Study Results

No Results Posted as of Oct 22, 2018