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A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.
This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linifanib | Experimental | Single Doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linifanib | Drug | Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion) Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calculate the Cmax and Tmax of participating subjects | PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. | The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis on Days 1 through 7 of Periods 1, 2 and 3. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the case report forms. All adverse events will be followed to a satisfactory clinical resolution. |
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Inclusion Criteria
Age is greater than or equal to 18 years.
Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
Subject must have adequate bone marrow, renal and hepatic function as follows:
Subject must have Partial Thromboplastin Time (PTT) \
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 51465 | Baltimore | Maryland | 21231 | United States | ||
| Site Reference ID/Investigator# 61282 |
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| All adverse events occuring from Day 1 of Period 1 through the Final Visit will be reported. |
| Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. | Physical exam at Screening, Day 1 of Periods 1, 2 and 3 and Day 5, Period 2 (FE portion), Day 5, Period 3 (BA Portion)/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits. |
| Safety: Clinical Lab Tests will be performed for each participant as a safety measure. | Chemistry, hematology, urinalysis lab tests | Screening, Day 1, Periods 1 and 2, Day 5, Period 2 (FE portion), Day 5, Period 3 (BA portion)/Final Visit and 30 day safety follow-up. |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Site Reference ID/Investigator# 51463 | Lebanon | New Hampshire | 03756-0001 | United States |
| Site Reference ID/Investigator# 52122 | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| C513486 | linifanib |
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