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To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5-mg Pomalidomide or placebo (Cohort A) | Experimental | A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions |
|
| 1-mg Pomalidomide or placebo (Cohort B) | Experimental | This arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. |
|
| 2-mg Pomalidomide or placebo (Cohort C) | Experimental | This arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug | 0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of participants with adverse events | 28 days after last dose |
| area under the plasma concentration-time curve | area under the plasma concentration-time curve | 72 hours after last dose |
| time to maximum observed plasma concentration | time to maximum observed plasma concentration | 72 hours after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| maximum observed plasma concentration | maximum observed plasma concentration | 72 hours after last dose |
| terminal elimination half-life | terminal elimination half-life |
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Inclusion Criteria:
Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Palmisano | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
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| Placebo | Drug | Placebo capsule |
|
| 72 hours after last dose |
| apparent total plasma clearance | apparent total plasma clearance | 72 hours after last dose |
| apparent total volume of distribution, and accumulation ratio | apparent total volume of distribution, and accumulation ratio | 72 hours after last dose |