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

COMPLETEDPHASE1

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

The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects

NCT03262727•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.

Eligibility

Age

18 - 40 years

Sex

FEMALE

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)

Locations (1)

Miami Research Associates

Miami, Florida, United States

Key Dates

Start Date

September 1, 2017

Primary Completion Date

November 23, 2017

Completion Date

December 19, 2017

Last Updated

March 19, 2020

Enrollment

ACTUAL participants

Conditions

Systemic Lupus ErythematosusArthritic PsoriasisPsoriasisInflammatory Bowel Diseases

Interventions

BMS-986165

DRUG

Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)

DRUG

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

View study

RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

NCT07371468

Systemic Lupus Erythematosus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis