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Replaced with another clinical trial
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The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactating women receiving treatment with Ozanimod and their infants | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast milk, plasma, and blood samples | Diagnostic Test | Although this study is non- interventional regarding treatment with ozanimod, the study is considered interventional due to the collection of breast milk and plasma from the lactating women and blood samples from their breastfed infants and the additional diagnostic and monitoring procedures required for the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Average concentration at steady state (Css-avg) in breast milk | Predose; Up to 24 hours post dose | |
| Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk | Predose; Up to 24 hours post dose | |
| Drug daily infant dose | Predose; Up to 24 hours post dose | |
| Drug relative infant dose | Predose; Up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to approximately 5 months | |
| Number of participants with clinical laboratory abnormalities | Up to approximately 5 months | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Las Vegas Clinical Research Unit | Las Vegas | Nevada | 89113-2228 | 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/disclosure-commitment.html
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Number of participants with vital sign abnormalities |
| Up to approximately 5 months |
| Number of participants with physical examination abnormalities | Up to approximately 5 months |
| Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough) | Predose; Up to 12 hours post dose |
| Maximum observed concentration in breast milk over the dosing interval (Cmax) | Predose; Up to 24 hours post dose |
| Minimum observed concentration in breast milk over the dosing interval (Cmin) | Predose; Up to 24 hours post dose |
| Time to reach Cmax (Tmax) | Predose; Up to 24 hours post dose |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |