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

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00549666

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: Lurasidone 40 mg Drug: Placebo 40 mg Drug: Ortho Tri-Cyclen	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Lurasidone 40 mg

Drug: Lurasidone 40 mg

Lurasidone 40 mg days 12-21 once daily

Placebo Comparator: Placebo

Drug: Placebo 40 mg

Placebo 40 mg once daily during treatment period

Active Comparator: Ortho Tri-Cyclen

Drug: Ortho Tri-Cyclen

Ortho Tri-Cyclen during 28-day lead in period

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.