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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ethinyl estradiol, norethindrone, VI-0521

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
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85283
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Contraceptive	Drug: ethinyl estradiol, norethindrone, VI-0521; Oral contraceptive; Other Names: VI-0521, Ortho-Novum 1/35-28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK of the Oral contraceptive agent	31 days

Secondary Outcome Measures

Outcome Measure	Time Frame
saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects	31

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: January 6, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimate): January 13, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2009
• Last Update Submitted That Met QC Criteria: November 30, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Oral Contraceptives; Multiple dose administration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Estradiol; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl
• Other Study ID Numbers: OB-108