18F-LY3950321-01 Biodistribution and Safety Study

NCT05775601 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 18F-LY3950321-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

18F-LY3950321 (also known as 18F-MNI-1256) is a radiolabeled positron emission tomography (PET) tracer targeting granzyme B. The overall goal of this protocol is to evaluate the safety, tolerability, and radiation dosimetry of 18F-LY3950321.

Conditions

Diagnostic Agent Adverse Reaction; Radiation Exposure

Outcome Measures

Primary Outcomes (1)

• 18F-LY3950321 Whole Body Effective Dose

  Radiation dose estimates. Distribution data will be utilized in the MIRD calculations of target organ radiation absorbed dose with correction from urine assays and standard GI kinetic models in Organ Level Internal Dose Assessment (OLINDA). Standard Medical Internal Radiation Dose (MIRD) assumptions will be incorporated in dosimetry models for determination of radiation absorbed doses in target organs and whole-body.

  injection to 4 hours postdose

Study Arms (1)

18F-LY3950321 Whole Body Dosimetry

EXPERIMENTAL

Drug: 18F-LY3950321; Procedure: PET Scan

Interventions

18F-LY3950321 DRUG

3 millicuries (±1 mCi)

Also known as: 18F-MNI-1256

18F-LY3950321 Whole Body Dosimetry

PET Scan PROCEDURE

positron emission tomography (PET) scan

18F-LY3950321 Whole Body Dosimetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy with no clinically relevant finding on physical examination at Screening and upon reporting to the clinic for the Imaging Visit.
• Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use contraception and not donate eggs.
• Male subjects with their partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male subjects for the study duration and 90 days after study completion.
• Male subjects must not donate sperm for the study duration and for 90 days after study completion.

You may not qualify if:

• Current or prior history of any alcohol or drug abuse in the past 2 years.
• Currently exposed to nicotine products or had regular nicotine exposure within a six-month period, to be verified by urine cotinine screening.
• ECG or Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
• Known history of hypersensitivity, including hypersensitivity to the active substances used for 18F-LY3950321 or derivatives, or to any of the associated excipients.
• Subject has received an investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
• Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 milliSieverts, including the procedures in this clinical protocol).
• Pregnant, lactating or breastfeeding.
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Unsuitable veins for repeated venipuncture.
• Use of any prescription drugs (except approved forms of birth control) or herbal supplements, within 4 weeks prior to Day 1.
• Use of any over-the-counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to Day 1.
• Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

Invicro, LLC

New Haven, Connecticut, 06510, United States

Location

Related Publications (3)

• Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med. 2005 Jun;46(6):1023-7.

  PMID: 15937315 BACKGROUND

• International Commission on Radiological Protection. Human alimentary tract model for radiological protection. ICRP Publication 100. A report of The International Commission on Radiological Protection. Ann ICRP. 2006;36(1-2):25-327, iii. doi: 10.1016/j.icrp.2006.03.004.

  PMID: 17188183 BACKGROUND

• Harrison J, Lopez PO. Use of effective dose in medicine. Ann ICRP. 2015 Jun;44(1 Suppl):221-8. doi: 10.1177/0146645315576096. Epub 2015 Mar 25.

  PMID: 25816282 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Avid Medical Director

  Avid Radiopharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: February 28, 2023
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)