Status:
COMPLETED
The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Arthritic Psoriasis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive,
- 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
- Exposure to an investigational agent within 12 weeks before Cycle 1 Day 1
- 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)
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03262727
Start Date
September 1 2017
End Date
December 19 2017
Last Update
March 19 2020
Active Locations (1)
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1
Miami Research Associates
Miami, Florida, United States, 33173-5426