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San Diego, California 92123


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


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.



Primary Contact:

Study Director
Medical Director, MD

Backup Contact:


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: October 09, 2019

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