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 Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986166

Drug: Oral contraceptive

Study type

Interventional

Funder types

Industry

Identifiers

NCT04934696

IM018-006

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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