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

A Phase 1 Study to Characterize the Effects of BMS-986166 on the Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Female Participants

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 Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986166; Drug: Oral contraceptive

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • West Coast Clinical Trials Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986166 + Oral contraceptive	Drug: BMS-986166; Specified dose on specified days; Drug: Oral contraceptive; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	Up to Day 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of BMS-986166		Up to Day 26
Cmax of BMT-121795		Up to Day 26
Time of maximum observed plasma concentration (Tmax) of BMS-986166		Up to Day 26
Tmax of BMT-121795		Up to Day 26
Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166		Up to Day 26
AUC(TAU) of BMT-121795		Up to Day 26
Tmax of EE		Up to Day 26
Tmax of NET		Up to Day 26
Terminal plasma elimination phase half-life (T-HALF) of EE		Up to Day 26
T-HALF of NET		Up to Day 26
Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE		Up to Day 26
CLT/F of NET		Up to Day 26
Apparent volume of distribution at terminal phase (Vz/F) of EE		Up to Day 26
Vz/F of NET		Up to Day 26
Number of participants with Adverse Events (AEs)		Up to Day 37
Number of participants with Serious Adverse Events (SAEs)		Up to Day 37
Number of participants with clinically significant changes in laboratory values: Hematology tests		Up to Day 30
Number of participants with clinically significant changes in laboratory values: Chemistry tests		Up to Day 30
Number of participants with clinically significant changes in laboratory values: Urinalysis		Up to Day 30
Number of participants with clinically significant changes in vital signs: Body temperature		Up to Day 27
Number of participants with clinically significant changes in vital signs: Respiratory rate		Up to Day 27
Number of participants with clinically significant changes in vital signs: Blood pressure		Up to Day 27
Number of participants with clinically significant changes in vital signs: Heart rate		Up to Day 27
Number of participants with clinically significant changes in ECG parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to Day 27
Number of participants with clinically significant changes in ECG parameters: QTcF	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave	Up to Day 27
Number of participants with physical examination abnormalities		Up to Day 27

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Healthy Participants; BMS-986166
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral
• Other Study ID Numbers: IM018-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No