Clinical trial NCT05891262: A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
Official title: A Phase 1, Single-center, Open-label, Single-sequence Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 With Oral Contraceptives in Healthy Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Female Volunteers
Keywords: Pharmacokinetics
BMS-986196
Hormonal contraceptives
Ethinyl estradiol
Norethindrone
Female volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol \[EE\] and norethindrone \[NET\]) in healthy female participants.


Eligibility criteria: Inclusion Criteria:

* Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles.
* Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m\^2), inclusive, at screening.
* Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.

Exclusion Criteria:

* Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
* History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
* Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: At Day 1 and Day 20
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: At Day 1 and Day 20
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
timeFrame: At Day 1 and Day 20
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: At Day 1 and Day 20
measure: Terminal half-life (T-HALF)
timeFrame: At Day 1 and Day 20
measure: Apparent total body clearance (CLT/F)
timeFrame: At Day 1 and Day 20
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 49
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to Day 49
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 49
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 49
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 49
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 49
measure: Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS)
timeFrame: Up to Day 49
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: