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

• ClinicalTrials.gov Identifier: NCT00549666
• Recruitment Status: Completed
• First Posted: October 26, 2007
• Last Update Posted: September 14, 2011
• Sponsor: Sunovion
• Information provided by (Responsible Party): Sunovion

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 (Clinical Trial)
• 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: August 2007
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 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

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Covance Global Clinical Pharmacology, Inc.

San Diego, California, United States, 92123

Sponsors and Collaborators

Sunovion

Investigators

• Study Director: Medical Director, MD; Sunovion

More Information

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT00549666
• Other Study ID Numbers: D1050246
• First Posted: October 26, 2007
• Last Update Posted: September 14, 2011
• Last Verified: September 2011

Keywords provided by Sunovion:

OC DDI; lurasidone; Latuda; schizophenia

Additional relevant MeSH terms:

Moxifloxacin; Lurasidone Hydrochloride; Norgestimate, ethinyl estradiol drug combination; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Adrenergic alpha-2 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors