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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986322 and Loestrin | Experimental | Loestrin, then progress to combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986322 | Drug | Specified dose on specified days |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Anaheim | California | 92801 | United States | ||
| Local Institution - 0002 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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| Loestrin |
| Drug |
Specified dose on specified days |
|
| 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 |
| Anaheim |
| California |
| 92801 |
| United States |
| ID | Term |
|---|---|
| C020416 | norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination |
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