A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential

Bristol-Myers Squibb25 enrolled

Overview

The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

BMS-986166DRUG

Specified dose on specified days

Oral contraceptiveDRUG

Specified dose on specified days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: * Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study. * Body mass index (BMI) of 18.0 to 32.0 kg/m². BMI = weight (kg)/(height\[m\])² for participants. * Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent. Exclusion Criteria: * Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor. * History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease. * Any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening. Other protocol-defined inclusion/exclusion criteria apply

Locations (1)

West Coast Clinical Trials Global

Cypress, California, United States

Outcomes

Primary Outcomes

Geometric means ratio of Cmax of NET

Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166

Time frame: Up to Day 26

Geometric means ratio of Cmax of EE

Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166

Time frame: Up to Day 26

Geometric means ratio of AUC(0-T) of NET

Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166

Time frame: Up to Day 26

Geometric means ratio of AUC(0-T) of EE

Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166

Time frame: Up to Day 26

Geometric means ratio of AUC(INF) of NET

Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166

Time frame: Up to Day 26

Geometric means ratio of AUC(INF) of EE

Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166

Time frame: Up to Day 26

Secondary Outcomes

Cmax of BMS-986166

Data from ClinicalTrials.gov

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