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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00549666
First received: October 24, 2007
Last updated: September 12, 2011
Last verified: September 2011

October 24, 2007
September 12, 2011
August 2007
December 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00549666 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Pharmacokinetics
  • Drug: Lurasidone 40 mg
    Lurasidone 40 mg days 12-21 once daily
  • Drug: Placebo 40 mg
    Placebo 40 mg once daily during treatment period
  • Drug: Ortho Tri-Cyclen
    Ortho Tri-Cyclen during 28-day lead in period
  • Experimental: Lurasidone 40 mg
    Intervention: Drug: Lurasidone 40 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo 40 mg
  • Active Comparator: Ortho Tri-Cyclen
    Intervention: Drug: Ortho Tri-Cyclen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00549666
D1050246
Yes
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP