Open-Label Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114)
- Conditions
- SchizophreniaBipolar Disorder IAutistic DisorderMental Health - Autistic spectrum disordersMental Health - Other mental health disordersMental Health - Schizophrenia
- Registration Number
- ACTRN12617001251314
- Lead Sponsor
- Delpor Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
Healthy adult male and non-pregnant females
1. Known hypersensitivity to titanium, implant materials or procedure;
2. Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures);
3. History of abnormal scar formation or family history of keloid formation;
4. Disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson’s disease.
5. History of treatment for marked depression, anxiety, tension, or agitation; currently on medication for asthma; use of any MAOI within 14 days prior to dosing; history of surgery requiring anesthesia within 8 weeks prior to start of dosing;
6. Blood or plasma donation within 30 days prior to start of dosing. All subjects will be advised not to donate blood or plasma for six weeks after completing the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method