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The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

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ClinicalTrials.gov Identifier: NCT03262740
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BMS-986195 Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : January 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986195 and Oral Contraceptive
Oral administration of contraceptive, then progress to combination
 Drug: BMS-986195
Oral administration of specified dose on specified days

Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
Oral Contraceptive


Outcome Measures
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Primary Outcome Measures :
  1. Maximum concentration (Cmax) derived from plasma concentration versus time [ Time Frame: Approximately 1 day ]
  2. Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time [ Time Frame: Approximately 1 day ]

Secondary Outcome Measures :
  1. Adverse events measured by incidence [ Time Frame: Approximately 86 days ]
  2. Serious adverse events measured by incidence [ Time Frame: Approximately 86 days ]

Eligibility Criteria
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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:

  • 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

Contacts and Locations
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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): NCT03262740


Locations
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United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03262740    
Other Study ID Numbers: IM014-023
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Estradiol
Branebrutinib
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined
Contraceptives, Oral, Sequential
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action