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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005425-75 | EudraCT Number |
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This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.
In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.
In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.
There will be a washout period of at least 14 days between Period 1 and Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPI-145 and [14C] IPI-145 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPI-145 | Drug | Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters (AUC) of IPI-145 in plasma | over 48 hours | |
| PK parameters (AUC) and radioactivity excreted in urine and feces | over 144 hours | |
| PK parameters (Cmax) of IPI-145 in plasma | over 48 hours | |
| PK parameters (t1/2) of IPI-145 in plasma | over 48 hours | |
| PK parameters (Cmax) and radioactivity excreted in urine and feces | over 144 hours | |
| PK parameters (t1/2) and radioactivity excreted in urine and feces | over 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events following a single dose administration of IPI-145 | over 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hagop Youssoufian, MD | Verastem, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceuticals Research Association (PRA) | Zuidlaren | Netherlands |
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| ID | Term |
|---|---|
| C586691 | duvelisib |
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