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

NCT00549666 | Completed Phase 1 DMC

• 1 other identifier: D1050246
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Keywords

OC DDI; lurasidone; Latuda; schizophenia

Study Arms (3)

Lurasidone 40 mg

EXPERIMENTAL

Drug: Lurasidone 40 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo 40 mg

Ortho Tri-Cyclen

ACTIVE COMPARATOR

Drug: Ortho Tri-Cyclen

Interventions

Lurasidone 40 mg DRUG

Lurasidone 40 mg days 12-21 once daily

Lurasidone 40 mg

Placebo 40 mg DRUG

Placebo 40 mg once daily during treatment period

Placebo

Ortho Tri-Cyclen DRUG

Ortho Tri-Cyclen during 28-day lead in period

Ortho Tri-Cyclen

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

Covance Global Clinical Pharmacology, Inc.

San Diego, California, 92123, United States

Location

MeSH Terms

Interventions

Lurasidone Hydrochloride; norgestimate, ethinyl estradiol drug combination

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 14, 2011

Record last verified: 2011-09

Locations

US (1)