A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Study Overview
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Brief Summary
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A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen

Official Title
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A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Lurasidone 40 mg
* Drug: Placebo 40 mg
* Drug: Ortho Tri-Cyclen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone 40 mg<br> | Drug: Lurasidone 40 mg<br>* Lurasidone 40 mg days 12-21 once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo 40 mg<br>* Placebo 40 mg once daily during treatment period<br>|
| Active Comparator: Ortho Tri-Cyclen<br> | Drug: Ortho Tri-Cyclen<br>* Ortho Tri-Cyclen during 28-day lead in period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OC DDI, lurasidone, Latuda, schizophenia