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

NCT ID: NCT00549666

Last Updated: 2011-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-12-31

Brief Summary

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

Conditions

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

Lurasidone 40 mg

Group Type: EXPERIMENTAL

Lurasidone 40 mg

Intervention Type: DRUG

Lurasidone 40 mg days 12-21 once daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo 40 mg

Intervention Type: DRUG

Placebo 40 mg once daily during treatment period

Ortho Tri-Cyclen

Group Type: ACTIVE_COMPARATOR

Ortho Tri-Cyclen

Intervention Type: DRUG

Ortho Tri-Cyclen during 28-day lead in period

Interventions

Lurasidone 40 mg

Lurasidone 40 mg days 12-21 once daily

Intervention Type: DRUG

Placebo 40 mg

Placebo 40 mg once daily during treatment period

Intervention Type: DRUG

Ortho Tri-Cyclen

Ortho Tri-Cyclen during 28-day lead in period

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Covance Global Clinical Pharmacology, Inc.

San Diego, California, United States

Countries

United States

Other Identifiers

D1050246

Identifier Type: -

Identifier Source: org_study_id