A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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.