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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832180
First Posted: July 14, 2016
Last Update Posted: December 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Arthritis Drug: OC containing EE and NET Drug: BMS-986142 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 25
Study Start Date: May 2016
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily single dose of OC containing EE and NET
Daily single dose of OC Containing EE and NET alone.
Drug: OC containing EE and NET
Experimental: Daily single dose of OC in combination with BMS-986142
Daily single dose of OC containing EE and NET in combination with BMS-986142.
Drug: OC containing EE and NET Drug: BMS-986142

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832180


Locations
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Indiana
Covance Evansville Clinical Research Unit
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02832180     History of Changes
Other Study ID Numbers: IM006-032
First Submitted: May 16, 2016
First Posted: July 14, 2016
Last Update Posted: December 26, 2016
Last Verified: December 2016

Keywords provided by Bristol-Myers Squibb:
Rheumatoid

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Contraceptive Agents
Norethindrone
Norethindrone acetate
Norinyl
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential