Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001944-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPI-145 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPI-145 | Drug | Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects | 8 months | |
| Plasma concentrations of IPI-145 and metabolites | 8 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hagop Youssoufian, MD | Verastem, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Zuidlaren | 9470 AE | Netherlands |
Not provided
| ID | Term |
|---|---|
| C586691 | duvelisib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm |
|