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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986196 and Loestrin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986196 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Note: 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 |
|---|---|---|---|---|---|---|
| Altasciences | Cypress | California | 90630 | United States |
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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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| ID | Term |
|---|---|
| C020416 | norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination |
| D004997 | Ethinyl Estradiol |
| D009640 | Norethindrone |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| Loestrin |
| Drug |
Specified dose on specified days |
|
|
| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |