Official Title: “A Phase I, Open Label, Fixed Sequence, Single-Center Study to Evaluate the Effect of Multiple Dose Administration of VI-0521 on the Pharmacokinetics of a Single Dose of Oral Contraceptive in Healthy Female Subjects”

This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: March 2009

This study is designed to determine if multiple oral doses of VI-0521 would alter the pharmacokinetics of an oral contraceptive in healthy female subjects.

Intervention(s) in this Clinical Trial

• Drug: ethinyl estradiol, norethindrone, VI-0521
  • Oral contraceptive

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Oral Contraceptive

Primary Measures

• PK of the Oral contraceptive agent
  • Time Frame: 31 days
    Safety Issue?: No

Secondary Measures

• saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects
  • Time Frame: 31
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Females, 19 - 64 years of age (inclusive), who are non-pregnant, not planning pregnancy and non-breast-feeding.
• 2. If females of child-bearing potential, be using adequate contraception, defined as double barrier methods, single barrier plus tubal ligation.
• 3. A body weight of at least 50 kg and a body mass index (BMI) between 27 and 35 kg/m2, inclusive.
• 4. Medically healthy, with clinically insignificant screening results.
• 5. Subjects are able to communicate with the investigator, and to understand and comply with all requirements of study participation.
• 6. Voluntarily consent to participate in the study.

Exclusion Criteria:

• 1. A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator.
• 2. Any clinically significant laboratory abnormalities as judged by the investigator.
• 3. Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
• 4. Presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy.
• 5. Any history of a cardiovascular or cerebrovascular event.
• 6. Systolic blood pressure > 150 mm Hg or diastolic blood pressure > 95 mm Hg at screening or at check-in on Day -1.
• 7. Positive urine drug test, serum cotinine test, pregnancy test and/or positive urine alcohol test at screening or check in Day -1.
• 8. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening.
• 9. Any history or presence of alcoholism or drug or substance abuse as defined by the investigator.
• 10. Any active malignancy except basal cell carcinoma.
• 11. A history of breast cancer.
• 12. Any history of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
• 13. A history of intolerance to oral contraceptives.
• 14. A history of hypersensitivity or idiosyncratic reaction to the active drugs, compounds related to the study drugs or to any excipients present in the VI-0521 capsule.
• 15. Use of any prescription or over-the-counter (OTC) medication, including herbal products, within the 14 days prior to Day -1. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator.
• 16. Use of any drug known to have a significance in inhibiting or inducing liver enzymes involved in drug metabolism [CYP P450]) within 30 days prior to Day -1.
• 17. Blood donation or significant blood loss within 56 days prior to Day -1.
• 18. Plasma donation within 7 days prior to Day -1.
• 19. Any use of tobacco or nicotine products within 3 months prior to Day -1.
• 20. Any history of celiac diseases, food allergies, and those on vegetarian or other diets incompatible with study objectives.
• 21. Any subject who received an investigational drug within 30 days or six half-lives, whichever is longer, prior to dosing in this study.
• 22. Clinical judgment by the investigator that the subject should not participate in the study.
• 23. Involvement in the planning and conduct of the study.
• 24. Any subject who has participated in a previous clinical trial with VI-0521.
• 25. Subjects with any condition possibly affecting drug absorption.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: VIVUS, Inc.

Overall Clinical Trial Officials and Contacts

Shiyin Yee Study Director VIVUS, Inc.  

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00821496

Study ID Number: OB-108

ClinicalTrials.gov Identifier: NCT00821496

Health Authority: United States: Food and Drug Administration