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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934696
• Other study ID #: IM018-006
• Status: Completed
• Phase: Phase 1
• Start date: August 3, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986166
Specified dose on specified days
• Oral contraceptive
Specified dose on specified days

Locations

Country	Name	City	State
United States	West Coast Clinical Trials Global	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Cmax of BMS-986166		Up to Day 26
Secondary	Cmax of BMT-121795		Up to Day 26
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-986166		Up to Day 26
Secondary	Tmax of BMT-121795		Up to Day 26
Secondary	Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166		Up to Day 26
Secondary	AUC(TAU) of BMT-121795		Up to Day 26
Secondary	Tmax of EE		Up to Day 26
Secondary	Tmax of NET		Up to Day 26
Secondary	Terminal plasma elimination phase half-life (T-HALF) of EE		Up to Day 26
Secondary	T-HALF of NET		Up to Day 26
Secondary	Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE		Up to Day 26
Secondary	CLT/F of NET		Up to Day 26
Secondary	Apparent volume of distribution at terminal phase (Vz/F) of EE		Up to Day 26
Secondary	Vz/F of NET		Up to Day 26
Secondary	Number of participants with Adverse Events (AEs)		Up to Day 37
Secondary	Number of participants with Serious Adverse Events (SAEs)		Up to Day 37
Secondary	Number of participants with clinically significant changes in laboratory values: Hematology tests		Up to Day 30
Secondary	Number of participants with clinically significant changes in laboratory values: Chemistry tests		Up to Day 30
Secondary	Number of participants with clinically significant changes in laboratory values: Urinalysis		Up to Day 30
Secondary	Number of participants with clinically significant changes in vital signs: Body temperature		Up to Day 27
Secondary	Number of participants with clinically significant changes in vital signs: Respiratory rate		Up to Day 27
Secondary	Number of participants with clinically significant changes in vital signs: Blood pressure		Up to Day 27
Secondary	Number of participants with clinically significant changes in vital signs: Heart rate		Up to Day 27
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants with physical examination abnormalities		Up to Day 27

External Links

•   BMS Clinical Trial Information
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