Expired Study
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San Diego, California 92123


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


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 is Available At:

Original ID:




Secondary ID:

Study Acronym:


Brief Title:

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

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

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:

40 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Medical Director, MD
Study Director

Study Dates

Start Date:August 2007
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:September 2011
Last Changed Date:September 12, 2011
First Received Date:October 24, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Lurasidone 40 mg
Description:Lurasidone 40 mg days 12-21 once daily
Arm Name:Lurasidone 40 mg
Intervention Type:Drug
Name:Placebo 40 mg
Description:Placebo 40 mg once daily during treatment period
Arm Name:Placebo
Intervention Type:Drug
Name:Ortho Tri-Cyclen
Description:Ortho Tri-Cyclen during 28-day lead in period
Arm Name:Ortho Tri-Cyclen

Study Arms

Study Arm Type:Experimental
Arm Name:Lurasidone 40 mg
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Active Comparator
Arm Name:Ortho Tri-Cyclen

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sunovion

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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