NCT02194491

A Positron Emission Tomography Occupancy Study Using Ligand [11C]AS2471907 and Following Oral Dosing of ASP3662

A Phase 1 11β-Hydroxysteroid Dehydrogenase 1 Enzyme Occupancy Study Using a Positron Emission Tomography Ligand [11C]AS2471907- ([11C]MOZAT) and Following Single Oral Dose Administration of ASP3662 in Healthy Male Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate a novel PET tracer (\[11C\]AS2471907), and to use \[11C\]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain prior to and following single oral dose administration of ASP3662.

Detailed description

This is a two-part study where Part 1 will assess the test/retest variability of the ligand (\[11C\]AS2471907). Part 2 will assess the level and time-course of enzyme occupancy following ASP3662 dosing. Subjects will be confined to the clinic for up to 2 days.

Conditions

• Pharmacokinetics of ASP3662
• Displacement of Radiotracer
• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	[11C]AS2471907	intravenous radiotracer
RADIATION	Positron Emission Tomography (PET)	Imaging scanning procedure
DRUG	ASP3662	oral

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-07-18
• Last updated: 2016-06-28

Locations

1 site across 1 country: United States