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

Pharmacokinetics Clinical Trial

— OC-DDI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549666
• Other study ID #: D1050246
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2007
• Last updated: September 12, 2011
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2011
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subject is female between 18 and 40 years of age

• Female subjects of reproductive potential will demonstrate a negative serum ß-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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Lurasidone 40 mg
Lurasidone 40 mg days 12-21 once daily
• Placebo 40 mg
Placebo 40 mg once daily during treatment period
• Ortho Tri-Cyclen
Ortho Tri-Cyclen during 28-day lead in period

Locations

Country	Name	City	State
United States	Covance Global Clinical Pharmacology, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States,