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Evaluate the Effect of Multiple Dose Administration in Healthy Female Subjects
This study is not yet open for participant recruitment.
Verified by VIVUS, Inc., January 2009
Sponsored by: VIVUS, Inc.
Information provided by: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00821496
  Purpose

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


Condition Intervention Phase
Healthy
Drug: ethinyl estradiol / norethindrone
Drug: VI-0521
Phase I

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Topiramate Ethinyl estradiol Phentermine Phentermine hydrochloride Norethindrone acetate Norethindrone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • PK of the Oral contraceptive agent [ Time Frame: 31 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects [ Time Frame: 31 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oral Contraceptive: Experimental Drug: ethinyl estradiol / norethindrone
Oral contraceptive
Drug: VI-0521
15/92 phentermine hydrochloride/topiramate

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.

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821496

Contacts
Contact: Shiyin Yee 650-934-5240 yee@vivus.com
Contact: John Burnett burnett@vivus.com

Locations
United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Shiyin Yee VIVUS, Inc.
Principal Investigator: Scott Sharples, M.D. MDS Pharma Services
  More Information

Responsible Party: Vivus, Inc. ( Shiyin Yee )
Study ID Numbers: OB-108
Study First Received: January 6, 2009
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00821496  
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Multiple dose administration
Oral Contraceptives

Study placed in the following topic categories:
Modicon
Estradiol valerate
Ethinyl Estradiol
Healthy
Estradiol 17 beta-cypionate
Norinyl
Phentermine
Estradiol
Norethindrone
Estradiol 3-benzoate
Topiramate
Mestranol
Polyestradiol phosphate
Norethindrone acetate

Additional relevant MeSH terms:
Estrogens
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Reproductive Control Agents
Hormones
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral, Sequential
Contraceptives, Oral, Hormonal
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009