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
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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 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 |

Arm | Intervention/treatment |
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Experimental: BMS-986195 and Oral Contraceptive
Oral administration of contraceptive, then progress to combination
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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 |
- Maximum concentration (Cmax) derived from plasma concentration versus time [ Time Frame: Approximately 1 day ]
- 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 ]
- Adverse events measured by incidence [ Time Frame: Approximately 86 days ]
- 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 |
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

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
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |