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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunovion
• Treatments: Contraceptive Agents; Contraceptives, Oral; Fluoroquinolones; Lurasidone Hydrochloride; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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.