A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
| City: |
|
Irving |
| State: |
|
Texas |
| Zip Code: |
|
70562 |
| Conditions: |
|
Schizophrenia |
| Purpose: |
|
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072
(also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
|
| Study Summary: |
|
Three active treatment groups and a placebo group are planned. Randomization will be
sequential by dose level across the sites with placebo assignments randomly inserted. Each
subject's participation will be approximately 8 months, including screening, treatment
period, and a 3-month follow-up period.
|
| Criteria: |
|
Inclusion Criteria:
- Diagnosis of chronic schizophrenia that is clinically stable
- Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive
- Stable antipsychotic medication regimen for >/= 2 months before Screening
- Be willing and able to be confined to an inpatient clinical research unit for a total
of 37 days during the course of the study
Exclusion Criteria:
- Aripiprazole used within 30 days before Screening
- History of intolerance of or allergy or hypersensitivity to aripiprazole, its
excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg,
or glycerol)
- Current diagnosis of an Axis I disorder other than schizophrenia
- History of seizure disorder or any condition associated with seizures
- History of neuroleptic malignant syndrome (NMS)
- Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C
antibodies
- Received medication by IM injection within 30 days before Screening
- Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used
within 30 days before Screening
- DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of
nicotine or caffeine dependence within 12 months before Screening
- Donation of blood or blood components within 4 weeks before Screening
|
| NCT ID: |
|
NCT01493726 |
| Primary Contact: |
|
Study Director
Robert Risinger, MD
Alkermes
Chris Southard
Phone: 919-418-4823
Email: csouthard@INCResearch.com
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Irving, Texas 70562
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 23, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|