Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Diego, California 92123


Purpose:

A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen


Criteria:

Inclusion Criteria: - Subject is female between 18 and 40 years of age - Female subjects of reproductive potential will demonstrate a negative serum β-human chorionic gonadotropin level consistent with the non-gravid state at the screening visit - Subject agrees to take the triphasic oral contraceptive, Ortho Tri-Cyclen™, throughout the study. - Subject has a history of regular menstrual periods with no substantial breakthrough bleeding episodes while taking Ortho Tri-Cyclen™. - Subject has a body mass index that is < 33 kg/m2 (see Appendix 1). - Subject is judged to be in good health - Subject must have a negative hepatiti and HIV antibody at screening. - Subject has no clinically significant abnormality on screening ECG. Exclusion Criteria: - Subject has a history of major GI abnormalities/peptic ulceration, hematological, genitourinary, cardiovascular (including hypertension), renal, hepatic, pulmonary, psychiatric, endocrine (including diabetes) or metabolic (including glaucoma), neurologic or cerebrovascular disease, or any history of cancer. - Subject has systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at screening. - Subject has a history of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any gastrointestinal surgery. - Subject has any other acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would limit the patient safety or confound the results of the study. - Subject has an ECG at screening with PR > 240 msec; QRS complex > 120 msec; QTcB > 450; or any significant morphologic changes other than nonspecific T-wave changes. - Subject is currently a user of any illicit drugs (including "recreational use") including marijuana, or has recently used illicit drugs, or has a history of drug or alcohol dependence in the past year or abuse within the last 3 months. - Subject consumes excessive amounts of alcohol - Subject has had surgery within last 12 weeks, donated a unit of blood (within 4 weeks), or participated in another clinical study within 30 days of screening. - Subjects with hypertension, hyperlipidemia, and diabetes should also be excluded. (See package circular under "Contraindications") - Subject has clinically significant abnormalities at screening clinical examination or laboratory safety tests - Subject has a prolactin level of over 200 ng/mL at screening.


NCT ID:

NCT00549666


Primary Contact:

Study Director
Medical Director, MD
Sunovion


Backup Contact:

N/A


Location Contact:

San Diego, California 92123
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.