A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants
- Registration Number
- NCT05579574
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
Inclusion Criteria
- Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
- Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
- Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter (mL)/minute (min)/1.732m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion Criteria
- Any significant acute or chronic medical illness.
- Any acute infection or febrile illness within 7 days before Day 1 of Cycle 2.
- Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BMS-986322 and Loestrin BMS-986322 Loestrin, then progress to combination BMS-986322 and Loestrin Loestrin Loestrin, then progress to combination
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET Up to 28 days AUC (tau) for EE/NET with BMS-986322 Up to 28 days Maximum observed plasma concentration (Cmax) for EE/NET Up to 28 days Cmax for EE/NET with BMS-986322 Up to 28 days
- Secondary Outcome Measures
Name Time Method Tmax for BMS-986322 Up to 31 days AUC (tau) for BMS-986322 Up to 31 days Number of participants with vital sign abnormalities Up to 119 days Time of maximum observed plasma concentration (Tmax) for EE/NET Up to 28 days Number of participants with physical examination abnormalities Up to 119 days Cmax for BMS-986322 Up to 31 days Number of participants with Adverse Events (AEs) Up to 119 days Number of participants with Serious AEs (SAEs) Up to 119 days Number of participants with electrocardiogram (ECG) abnormalities Up to 119 days Tmax for BMS-986322 with EE/NET Up to 31 days AUC (tau) for BMS-986322 with EE/NET Up to 31 days Cmax for BMS-986322 with EE/NET Up to 31 days Number of participants with clinical laboratory abnormalities Up to 119 days Tmax for EE/NET with BMS-986322 Up to 28 days
Trial Locations
- Locations (2)
Local Institution - 0001
🇺🇸Anaheim, California, United States
Local Institution - 0002
🇺🇸Anaheim, California, United States