Ignite Creation Date:
2024-05-06 @ 3:47 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02370602
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2015-02-18
Brief Title:
An 11CT-773 Positron Emission Tomography PET Study to Determine Phosphodiesterase10A Occupancy by TAK-063
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open-Label 11CT-773 Positron Emission Tomography Study to Determine Phosphodiesterase10A Occupancy by TAK-063 After a Single Oral Dose in Human Volunteers
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11CT-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
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 11CT-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-004576-18 | EUDRACT_NUMBER | WHO | None |
| U1111-1165-3362 | REGISTRY | None | None |