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Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00821496
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : December 2, 2009
Information provided by:

Tracking Information
First Submitted Date  ICMJE January 6, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE January 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
PK of the Oral contraceptive agent [ Time Frame: 31 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects [ Time Frame: 31 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
Official Title  ICMJE 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
Brief Summary This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: ethinyl estradiol, norethindrone, VI-0521
Oral contraceptive
Other Name: VI-0521, Ortho-Novum 1/35-28
Study Arms  ICMJE Experimental: Oral Contraceptive
Intervention: Drug: ethinyl estradiol, norethindrone, VI-0521
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2009)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00821496
Other Study ID Numbers  ICMJE OB-108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wesley Day, VP Clinical, Vivus, Inc.
Original Responsible Party John Burnett, Vivus, Inc.
Current Study Sponsor  ICMJE VIVUS LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shiyin Yee VIVUS LLC
Principal Investigator: Scott Sharples, M.D. MDS Pharma Services
Verification Date November 2009

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