Trials / Completed
CompletedNCT00805454
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
A Phase I, Open-Label,Positron Emission Tomography (PET) Study Healthy Subjects Following a Single Oral Dose of OPC-34712
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
Detailed description
Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-34712 | Single oral dose, 0.5 to 25 mg |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
- First posted
- 2008-12-09
- Last updated
- 2010-05-07
Source: ClinicalTrials.gov record NCT00805454. Inclusion in this directory is not an endorsement.