|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01082263 |
|
Date of registration:
|
05/03/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Midazolam Drug-Drug Interaction Study With Lurasidone HCl
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
October 2008 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01082263 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Marina Bussel, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CCT/Parexel |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders
2. Females who participate in this study:
are unable to have children -OR- are willing to remain abstinent from Day -5 to 90
days after discharge; -OR- are willing to use an effective method of double-barrier
birth control from Day -5 to 90 days after discharge.
3. Males must be willing to remain sexually abstinent or use an effective method of
birth control from Day -5 to 90 days after discharge.
4. Able and agree to remain off of prior antipsychotic medication for the duration of
the study.
Exclusion Criteria:
1. Known presence or history of renal or hepatic insufficiency.
2. A history or presence of abnormal electrocardiogram (ECG5. Known history or presence
of clinically significant intolerance to antipsychotic medications.
3. Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30
mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
4. Presence or history (within the last year) of a medical or surgical condition (e.g.
gastrointestinal disease) that might interfere with the absorption, metabolism, or
excretion of orally administered lurasidone.
5. Participated in another clinical trial or receiving an investigational product within
30 days prior to drug administration.
6. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior
to Day -5 to follow-up including but not limited to those listed in Appendix 19.5.
7. Received depot neuroleptics unless the last injection was at least 1 treatment cycle
before Day -5.
8. Difficulty fasting or consuming the FDA high fat meals.
9. At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the
opinion of the investigator.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Schizophrenia Patients
|
|
Intervention(s)
|
|
Drug: Lurasidone HCl
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|