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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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: Lurasidone 40 mg (Drug); Placebo 40 mg (Drug); Ortho Tri-Cyclen (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Medical Director, MD, Study Director, Affiliation: Sunovion

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

Covance Global Clinical Pharmacology, Inc., San Diego, California 92123, United States
Additional Information

Starting date: August 2007
Last updated: September 12, 2011

Page last updated: August 23, 2015

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