Clinical trial NCT03262740: The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
Official title: The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of BMS-986195 in combination with an oral contraceptive in healthy female patients.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Maximum concentration (Cmax) derived from plasma concentration versus time
timeFrame: Approximately 1 day
measure: Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time
timeFrame: Approximately 1 day
Secondary outcomes:
measure: Adverse events measured by incidence
timeFrame: Approximately 86 days
measure: Serious adverse events measured by incidence
timeFrame: Approximately 86 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: