Clinical trial NCT00549666: A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: OC DDI
lurasidone
Latuda
schizophenia
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Covance Global Clinical Pharmacology, Inc.
state: California
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: