Hepatitis C VirusPhase 1NCT01063023
Drug Interaction Oral Contraceptive Pill (OCP)
A Phase 1 study testing Ortho Tri-Cyclen® and BMS-650032 in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- Ortho Tri-Cyclen® and BMS-650032
- 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 2010to Jun 2010
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug
Who cannot join
- Abnormal pap smear within 1 year prior to day 1
- Any significant or chronic uncontrolled medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
- Conditions
- Hepatitis C Virus
- Being tested
- Ortho Tri-Cyclen®, BMS-650032
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortho Tri-Cyclen®Drug
Tablets, Oral, 1 Tablet, once daily
BMS-650032Drug
Tablets, Oral, 600 mg, BID
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Ortho Tri-Cyclen® | Active comparator | 1 to 28 days Receives: Drug: Ortho Tri-Cyclen® |
| Arm B - Ortho Tri-Cyclen® | Active comparator | 29 to 56 days Receives: Drug: Ortho Tri-Cyclen® |
| Arm C - Ortho Tri-Cyclen® + BMS-650032 | Active comparator | Ortho Tri-Cyclen®: 57 to 77 days
BMS-650032: 68 to 77 days Receives: Drug: Ortho Tri-Cyclen®; Drug: BMS-650032 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
Measured: 24 hours of dosing
Secondary outcomes (2)
To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered
Measured: Safety will be assessed through day 78
To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination
Measured: PK assessments will be done on Day 49, 50, 77 and 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063023
- Sponsor's protocol ID
- AI447-019
- Status last verified
- Jun 2010
- First submitted
- 3 Feb 2010
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01063023
- Acronym / sponsor ID
- AI447-019
- Conditions
- Hepatitis C Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Feb 2010 (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.
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A - Ortho Tri-Cyclen® | Active comparator | Drug: Ortho Tri-Cyclen®1 to 28 days |
| Arm B - Ortho Tri-Cyclen® | Active comparator | Drug: Ortho Tri-Cyclen®29 to 56 days |
| Arm C - Ortho Tri-Cyclen® + BMS-650032 | Active comparator | Drug: Ortho Tri-Cyclen®, Drug: BMS-650032Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug
Key exclusion criteria (2 listed)
- Abnormal pap smear within 1 year prior to day 1
- Any significant or chronic uncontrolled medical illness
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 |
|---|---|---|
| Ortho Tri-Cyclen®Tablets, Oral, 1 Tablet, once daily | Drug | Arm A - Ortho Tri-Cyclen®, Arm B - Ortho Tri-Cyclen®, Arm C - Ortho Tri-Cyclen® + BMS-650032 |
| BMS-650032Tablets, Oral, 600 mg, BID | Drug | Arm C - Ortho Tri-Cyclen® + BMS-650032 |
Primary outcome
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
Time frame: 24 hours of dosing
2 secondary outcomes
To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered
Time frame: Safety will be assessed through day 78
To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination
Time frame: PK assessments will be done on Day 49, 50, 77 and 78
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 25 Jan 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Ortho Tri-Cyclen® and BMS-650032 in people with Hepatitis C Virus, run by Bristol-Myers Squibb 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 1 inclusion and 2 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 25 Jan 2011. 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?
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) (time frame: 24 hours of dosing). 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 25 Jan 2011.