Conditions: Healthy Volunteers
Keywords: Drug therapy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 13
Healthy volunteers: yes

Brief summary:
The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain following a single dose of TAK-063.

Detailed description:
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.

Arms:
arm 1: \[\^11C\]T-773 \<8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 prior to PET scans and TAK-063 30 mg or 1000 mg, tablets, orally, once on Day 2 and after PET scan #2 and prior to PET scan #3 and \[\^11C\]T-773 IV after TAK-063 and prior to PET scan #3 on Day 2. arm 2: TAK-063 3 to 100 mg, tablets, orally, once, on Day 1, and \[\^11C\]T-773 \<8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2 .

Interventions: intervention 1: TAK-063 intervention 2: [^11C]T-773
Intervention descriptions: intervention 1: TAK-063 tablets intervention 2: \[\^11C\]T-773 IV solution

Protocol document: