Pharmacokinetics
Conditions
Keywords
OC DDI, lurasidone, Latuda, schizophenia
Brief summary
A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
Interventions
DRUGLurasidone 40 mg
Lurasidone 40 mg days 12-21 once daily
DRUGPlacebo 40 mg
Placebo 40 mg once daily during treatment period
DRUGOrtho Tri-Cyclen
Ortho Tri-Cyclen during 28-day lead in period
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Countries
United States
Outcome results
None listed