Clinical trial NCT02832180: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis
Keywords: Rheumatoid
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of EE and NET
timeFrame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
measure: Area under the concentration-time curve (AUC) of EE and NET
timeFrame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
measure: Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
timeFrame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Secondary outcomes:
measure: Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.
timeFrame: Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Evansville
country: United States
facility: Covance Evansville Clinical Research Unit
state: Indiana
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: