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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Lurasidone 40 mg; Drug: Placebo 40 mg; Drug: Ortho Tri-Cyclen

• Registration Number: NCT00549666
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-26
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-12
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lurasidone 40 mg	Lurasidone 40 mg	-
Placebo	Placebo 40 mg	-
Ortho Tri-Cyclen	Ortho Tri-Cyclen	-

Trial Locations

Locations (1)

Covance Global Clinical Pharmacology, Inc.; 🇺🇸 San Diego, California, United States