The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
NCT ID: NCT03262740
Last Updated: 2020-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2017-09-11
2018-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMS-986195 and Oral Contraceptive
Oral administration of contraceptive, then progress to combination
BMS-986195
Oral administration of specified dose on specified days
Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
Oral Contraceptive
Interventions
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BMS-986195
Oral administration of specified dose on specified days
Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
Oral Contraceptive
Eligibility Criteria
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Inclusion Criteria
* Weight ≥ 50 kg
* Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day 1
* Women of childbearing potential with intact ovarian function, on a stable regimen of combination birth control containing EE without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Cycle 1 Day -1
* Subjects aged 21 years or older must have a normal Pap smear result within 3 years before Cycle 1 Day 1 (a Pap smear may be performed at screening if no result is available); a finding of abnormal squamous cells of unknown significance (ASCUS) is allowed provided it is an initial finding and not a follow up from an initial finding of ASCUS
Exclusion Criteria
* Subjects who are pregnant or breastfeeding
* Any significant acute or chronic medical illness including infection, any active infection, febrile illness within 7 days before Cycle 1, Day 1, or any condition that could predispose the subject to infection
* History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months)
* Any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
* Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc)
18 Years
40 Years
FEMALE
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Miami Research Associates
South Miami, Florida, United States
PRA Health Sciences
Salt Lake City, Utah, United States
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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IM014-023
Identifier Type: -
Identifier Source: org_study_id
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