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
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Drug: Lurasidone 40 mg
Drug: Placebo 40 mg
Drug: Ortho Tri-Cyclen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Enrollment: 23
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549666

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

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00549666     History of Changes
Other Study ID Numbers: D1050246
Study First Received: October 24, 2007
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
OC DDI
lurasidone
Latuda
schizophenia

Additional relevant MeSH terms:
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Moxifloxacin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Anti-Infective Agents
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on April 16, 2014