HealthyPhase 1NCT00821496
Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
A Phase 1 study testing ethinyl estradiol, norethindrone, VI-0521 in people with Healthy, run by VIVUS LLC at 1 site in United States.
Trial summary
This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ethinyl estradiol, norethindrone, VI-0521
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Blood donation or significant blood loss within 56 days prior to Day -1.
- Plasma donation within 7 days prior to Day -1.
- Any use of tobacco or nicotine products within 3 months prior to Day -1.
- Any history of celiac diseases, food allergies, and those on vegetarian or other diets incompatible with study objectives.
- Any subject who received an investigational drug within 30 days or six half-lives, whichever is longer, prior to dosing in this study.
- Clinical judgment by the investigator that the subject should not participate in the study.
- Involvement in the planning and conduct of the study.
- Any subject who has participated in a previous clinical trial with VI-0521.
- Subjects with any condition possibly affecting drug absorption.
Trial locations and contacts
1 site in 1 country.
About this 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
This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.
Read the 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.
- Conditions
- Healthy
- Being tested
- ethinyl estradiol, norethindrone, VI-0521
- Keywords
- Multiple dose administration, Oral Contraceptives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethinyl estradiol, norethindrone, VI-0521Drug
Also called VI-0521, Ortho-Novum 1/35-28
Oral contraceptive
| Study group | Role | What they receive |
|---|---|---|
| Oral Contraceptive | Experimental | Not described Receives: Drug: ethinyl estradiol, norethindrone, VI-0521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK of the Oral contraceptive agent
Measured: 31 days
Secondary outcomes (1)
saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects
Measured: 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shiyin Yee, Study director, VIVUS LLCScott Sharples, M.D., Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821496
- Sponsor's protocol ID
- OB-108
- Status last verified
- Nov 2009
- First submitted
- 6 Jan 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00821496
- Acronym / sponsor ID
- OB-108
- Conditions
- Healthy
- Keywords
- Multiple dose administration, Oral Contraceptives
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Contraceptive | Experimental | Drug: ethinyl estradiol, norethindrone, VI-0521 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethinyl estradiol, norethindrone, VI-0521Also: VI-0521, Ortho-Novum 1/35-28Oral contraceptive | Drug | Oral Contraceptive |
Primary outcome
PK of the Oral contraceptive agent
Time frame: 31 days
1 secondary outcome
saftey and tolerability of multiple dose adminstration of VI-0521 in healthy female subjects
Time frame: 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyin Yee study director
VIVUS LLC
Scott Sharples, M.D. principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ethinyl estradiol, norethindrone, VI-0521 in people with Healthy, run by VIVUS LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK of the Oral contraceptive agent (time frame: 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.