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

• ClinicalTrials.gov Identifier: NCT00821496
• Recruitment Status: Completed
• First Posted: January 13, 2009
• Last Update Posted: December 2, 2009
• Sponsor: VIVUS LLC
• Information provided by: VIVUS LLC

Tracking Information

• First Submitted Date: January 6, 2009
• First Posted Date: January 13, 2009
• Last Update Posted Date: December 2, 2009
• Study Start Date: January 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 9, 2009): PK of the Oral contraceptive agent [ Time Frame: 31 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

Drug: ethinyl estradiol, norethindrone, VI-0521

Oral contraceptive

Other Name: VI-0521, Ortho-Novum 1/35-28

Study Arms

Experimental: Oral Contraceptive

Intervention: Drug: ethinyl estradiol, norethindrone, VI-0521

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 9, 2009): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 19 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00821496
• Other Study ID Numbers: OB-108
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
• Original Responsible Party: John Burnett, Vivus, Inc.
• Current Study Sponsor: VIVUS LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Shiyin Yee; VIVUS LLC
• Principal Investigator: Scott Sharples, M.D.; MDS Pharma Services

• PRS Account: VIVUS LLC
• Verification Date: November 2009