A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986322
* Drug: Loestrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986322 and Loestrin<br>Loestrin, then progress to combination | Drug: BMS-986322<br>* Specified dose on specified days<br>Drug: Loestrin<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) for EE/NET |  | Up to 28 days | 
| Cmax for EE/NET with BMS-986322 |  | Up to 28 days | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax for BMS-986322 |  | Up to 31 days | 
| Cmax for BMS-986322 with EE/NET |  | Up to 31 days | 
| AUC (tau) for BMS-986322 |  | Up to 31 days | 
| AUC (tau) for BMS-986322 with EE/NET |  | 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 physical examination abnormalities |  | Up to 119 days | 
| Number of participants with vital sign abnormalities |  | Up to 119 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 119 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 119 days | 
| Time of maximum observed plasma concentration (Tmax) for EE/NET |  | Up to 28 days | 
| Tmax for EE/NET with BMS-986322 |  | Up to 28 days | 
| Tmax for BMS-986322 |  | Up to 31 days | 
| Tmax for BMS-986322 with EE/NET |  | Up to 31 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986322, Loestrin, Combined oral hormonal contraceptive, Ethinyl Estradiol, Norethindrone, Drug-drug interaction