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

NCT00821496 | Completed Phase 1

• 1 other identifier: OB-108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Multiple dose administration; Oral Contraceptives

Outcome Measures

Primary Outcomes (1)

• PK of the Oral contraceptive agent

  31 days

Secondary Outcomes (1)

• saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects

  31

Study Arms (1)

Oral Contraceptive

EXPERIMENTAL

Drug: ethinyl estradiol, norethindrone, VI-0521

Interventions

ethinyl estradiol, norethindrone, VI-0521 DRUG

Oral contraceptive

Also known as: VI-0521, Ortho-Novum 1/35-28

Oral Contraceptive

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Any clinically significant laboratory abnormalities as judged by the investigator.
• Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
• Presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy.
• Any history of a cardiovascular or cerebrovascular event.
• Systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 95 mm Hg at screening or at check-in on Day -1.
• Positive urine drug test, serum cotinine test, pregnancy test and/or positive urine alcohol test at screening or check in Day -1.
• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening.
• Any history or presence of alcoholism or drug or substance abuse as defined by the investigator.
• Any active malignancy except basal cell carcinoma.
• A history of breast cancer.
• Any history of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
• A history of intolerance to oral contraceptives.
• 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.
• 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.

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

MDS Pharma Services

Phoenix, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Ethinyl Estradiol; Norethindrone

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnenes

Study Officials

• Shiyin Yee

  VIVUS LLC

  STUDY DIRECTOR

• Scott Sharples, M.D.

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 13, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-11

Locations

US (1)