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The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

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ClinicalTrials.gov Identifier: NCT03262727
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Arthritic Psoriasis Psoriasis Inflammatory Bowel Diseases Drug: BMS-986165 Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : December 19, 2017


Arm Intervention/treatment
Experimental: BMS-986165 and Oral Contraceptive
Oral administration of contraceptive, then progress to combination
Drug: BMS-986165
Oral administration of specified dose on specified days

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




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 ]


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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


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): NCT03262727


Locations
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173-5426
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03262727     History of Changes
Other Study ID Numbers: IM011-039
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Inflammatory Bowel Diseases
Lupus Erythematosus, Systemic
Arthritis, Psoriatic
Skin Diseases, Papulosquamous
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Mestranol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Norethindrone