Clinical trial NCT04934696: A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
BMS-986166
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Geometric means ratio of Cmax of NET
timeFrame: Up to Day 26
measure: Geometric means ratio of Cmax of EE
timeFrame: Up to Day 26
measure: Geometric means ratio of AUC(0-T) of NET
timeFrame: Up to Day 26
measure: Geometric means ratio of AUC(0-T) of EE
timeFrame: Up to Day 26
measure: Geometric means ratio of AUC(INF) of NET
timeFrame: Up to Day 26
measure: Geometric means ratio of AUC(INF) of EE
timeFrame: Up to Day 26
Secondary outcomes:
measure: Cmax of BMS-986166
timeFrame: Up to Day 26
measure: Cmax of BMT-121795
timeFrame: Up to Day 26
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986166
timeFrame: Up to Day 26
measure: Tmax of BMT-121795
timeFrame: Up to Day 26
measure: Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166
timeFrame: Up to Day 26
measure: AUC(TAU) of BMT-121795
timeFrame: Up to Day 26
measure: Tmax of EE
timeFrame: Up to Day 26
measure: Tmax of NET
timeFrame: Up to Day 26
measure: Terminal plasma elimination phase half-life (T-HALF) of EE
timeFrame: Up to Day 26
measure: T-HALF of NET
timeFrame: Up to Day 26
measure: Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE
timeFrame: Up to Day 26
measure: CLT/F of NET
timeFrame: Up to Day 26
measure: Apparent volume of distribution at terminal phase (Vz/F) of EE
timeFrame: Up to Day 26
measure: Vz/F of NET
timeFrame: Up to Day 26
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 37
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 37
measure: Number of participants with clinically significant changes in laboratory values: Hematology tests
timeFrame: Up to Day 30
measure: Number of participants with clinically significant changes in laboratory values: Chemistry tests
timeFrame: Up to Day 30
measure: Number of participants with clinically significant changes in laboratory values: Urinalysis
timeFrame: Up to Day 30
measure: Number of participants with clinically significant changes in vital signs: Body temperature
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in vital signs: Blood pressure
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in vital signs: Heart rate
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in ECG parameters: PR interval
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in ECG parameters: QRS
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in ECG parameters: QT interval
timeFrame: Up to Day 27
measure: Number of participants with clinically significant changes in ECG parameters: QTcF
timeFrame: Up to Day 27
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 27
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials Global
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: