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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted) | Experimental |
| |
| Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted) | Experimental |
| |
| Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed) | Experimental |
| |
| Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iberdomide | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose) | |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) | Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose) | |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) | Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Up to 28 days | |
| Number of Participants with Vital Sign Abnormalities | Up to 20 days | |
| Number of Participants with Clinical Laboratory Abnormalities |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Daytona Beach | Florida | 32117 | 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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|
| Up to 20 days |
| Number of Participants with Electrocardiogram Abnormalities | Up to 20 days |
| Number of Participants with Physical Examination Abnormalities | Up to 20 days |
| ID | Term |
|---|---|
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000624220 | iberdomide |
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