Healthy Volunteers Clinical Trial
Official title:
An Open-Label [^11C]T-773 Positron Emission Tomography Study to Determine Phosphodiesterase10A Occupancy by TAK-063 After a Single Oral Dose in Human Volunteers
The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain following a single dose of TAK-063.
The drug being tested in this study is called TAK-063. TAK-063 is was tested to estimate
phosphodiesterase10A (PDE10A) occupancy in the brain following a single dose of TAK-063.
This study used positron emission tomography (PET) scans to look at changes in the volume of
tissue distribution before and after TAK-063 administration to calculate PDE10A occupancy in
the brain.
The study enrolled 13 participants. Participants were assigned to a treatment group based on
an enrollment schedule. The first 4 participants were assigned to the Pilot Cohort and
received one dose of TAK-063 30 mg or 1000 mg tablets. The remaining participants were
enrolled into the Main Cohort and received one dose of TAK-063 at 3, 10, 30 or 100 mg.
Participants in both cohorts also received 3 separate intravenous infusions of [^11C]T-773
<8 μg; 400MBq ± 10% followed by a PET scan.
This single-centre trial was conducted in Sweden. The overall time to participate in this
study was 46 days. Participants made 3 visits to the clinic, including one 3-day period of
confinement to the clinic. Participants were contacted by phone on Day 16 for follow-up
safety assessments.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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