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

Sumitomo Pharma

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Drug: Ortho Tri-Cyclen

Drug: Placebo 40 mg

Drug: Lurasidone 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549666

D1050246

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.