ArthritisPhase 1NCT02832180
The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects
A Phase 1 study testing OC containing EE and NET and BMS-986142 in people with Arthritis, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate. 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
- Arthritis
- What is being tested?
- OC containing EE and NET and BMS-986142
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Oct 2016
- 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
- Signed Informed Consent
- Target population: Healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests that are willing to switch to Loestrin during the study.
- Body Mass Index (BMI) between 18 to 32 kg/m2.
- Women of childbearing potential with intact ovarian function and history of regular menstrual cycles must have been on a stable regimen of combination of birth control containing ethinyl estradiol without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1.
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs (53 days) plus 5 half-lives of BMS-986142 (3 days) plus 30 days (duration of ovulatory cycle) for a total of 86 days.
Who cannot join
- History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- History of jaundice or irregular bleeding associated with taking oral contraceptives, frequent headaches, cerebrovascular or coronary-artery disease, retinal vascular lesions, cancer of the breast or endometrium, deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, or phlebitis.
- Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance Evansville Clinical Research Unit
Evansville, Indiana, 47710
Miami Research Associates
Miami, Florida, 33143
About this study
Official title: The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.
- Conditions
- Arthritis
- Being tested
- OC containing EE and NET, BMS-986142
- Keywords
- Rheumatoid
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC containing EE and NETDrug
BMS-986142Drug
| Study group | Role | What they receive |
|---|---|---|
| Daily single dose of OC containing EE and NET | Experimental | Daily single dose of OC Containing EE and NET alone. Receives: Drug: OC containing EE and NET |
| Daily single dose of OC in combination with BMS-986142 | Experimental | Daily single dose of OC containing EE and NET in combination with BMS-986142. Receives: Drug: OC containing EE and NET; Drug: BMS-986142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of EE and NET
Measured: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve (AUC) of EE and NET
Measured: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
Measured: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Secondary outcomes (1)
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.
Measured: Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832180
- Sponsor's protocol ID
- IM006-032
- Status last verified
- Dec 2016
- First submitted
- 16 May 2016
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT02832180
- Acronym / sponsor ID
- IM006-032
- Conditions
- Arthritis
- Keywords
- Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Jul 2016 (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 is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily single dose of OC containing EE and NET | Experimental | Drug: OC containing EE and NETDaily single dose of OC Containing EE and NET alone. |
| Daily single dose of OC in combination with BMS-986142 | Experimental | Drug: OC containing EE and NET, Drug: BMS-986142Daily single dose of OC containing EE and NET in combination with BMS-986142. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- Target population: Healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests that are willing to switch to Loestrin during the study.
- Body Mass Index (BMI) between 18 to 32 kg/m2.
- Women of childbearing potential with intact ovarian function and history of regular menstrual cycles must have been on a stable regimen of combination of birth control containing ethinyl estradiol without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1.
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs (53 days) plus 5 half-lives of BMS-986142 (3 days) plus 30 days (duration of ovulatory cycle) for a total of 86 days.
Key exclusion criteria (5 listed)
- History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- History of jaundice or irregular bleeding associated with taking oral contraceptives, frequent headaches, cerebrovascular or coronary-artery disease, retinal vascular lesions, cancer of the breast or endometrium, deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, or phlebitis.
- Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
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 |
|---|---|---|
| OC containing EE and NET | Drug | Daily single dose of OC containing EE and NET, Daily single dose of OC in combination with BMS-986142 |
| BMS-986142 | Drug | Daily single dose of OC in combination with BMS-986142 |
Primary outcome
Maximum observed plasma concentration (Cmax) of EE and NET
Time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve (AUC) of EE and NET
Time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
Time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
1 secondary outcome
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.
Time frame: Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.
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 26 Dec 2016.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OC containing EE and NET and BMS-986142 in people with Arthritis, run by Bristol-Myers Squibb at 2 sites 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 5 inclusion and 5 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 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Maximum observed plasma concentration (Cmax) of EE and NET (time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)). The study lists 3 primary outcomes in all. 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 26 Dec 2016.