A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants

Phase 1

Completed

• Conditions: Healthy Female Volunteers
• Interventions: Drug: BMS-986196; Drug: Loestrin

• Registration Number: NCT05891262
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Study Start: 2023-06-06
• Study First Posted: 2023-06-06
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986196 and Loestrin	BMS-986196	-
BMS-986196 and Loestrin	Loestrin	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])	At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])	At Day 1 and Day 20

Secondary Outcome Measures

Name	Time	Method
Time of maximum observed plasma concentration (Tmax)	At Day 1 and Day 20
Terminal half-life (T-HALF)	At Day 1 and Day 20
Apparent total body clearance (CLT/F)	At Day 1 and Day 20
Number of participants with Adverse Events (AEs)	Up to Day 49
Number of participants with Serious AEs (SAEs)	Up to Day 49
Number of participants with clinical laboratory abnormalities	Up to Day 49
Number of participants with vital sign abnormalities	Up to Day 49
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 49
Number of participants with physical examination abnormalities	Up to Day 49
Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS)	Up to Day 49

Trial Locations

Locations (1)

Altasciences; 🇺🇸 Cypress, California, United States