NCT03695926

Assessment of [18F]MNI-1054 as a Marker for LSD1

An Open-label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-1054 as a Marker for LSD1 in Healthy Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this protocol is to evaluate \[18F\]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical.

Detailed description

The primary objective of this protocol is to evaluate \[18F\]MNI-1054 as a Lysine-specific histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical. The specific objectives are: * To measure the dynamic uptake and washout of \[18F\]MNI-1054 in brain using positron emission tomography (PET) in healthy volunteers. * To measure blood metabolites of \[18F\]MNI-1054 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess its ability to measure LSD1 in the brain. * To acquire safety data following injection of \[18F\]MNI-1054 * Evaluation of \[18F\]MNI-1054 PET reliability (test/retest) of the tracer parameters in healthy volunteers.

Conditions

• Healthy Volunteers (HV)

Interventions

Type	Name	Description
DRUG	[18F]MNI-1054	Healthy volunteers recruited for the study will undergo a \[18F\]MNI-1054 PET scan.

Timeline

• Start date: 2018-08-09
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2018-10-04
• Last updated: 2019-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study