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This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B). Part A will be a randomized, single-dose, open-label, three-treatment period crossover study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted conditions. Following review of safety data of the 200 mg dose level, an additional 12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: E7050 100 mg tablet under fasted conditions | Experimental | Participants will receive a single tablet containing 100 mg E7050 following an overnight fast. |
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| Part A: E7050 100 mg tablet with low-fat breakfast | Experimental | Participants will receive a single tablet containing 100 mg E7050 with a standard low-fat meal. |
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| Part A: E7050 100 mg tablet with high-fat breakfast | Experimental | Participants will receive a single tablet containing 100 mg E7050 with a standard high-fat meal. |
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| Part B: E7050 200 mg tablet under fasted conditions | Experimental | Participants will receive a single dose of 200 mg (two 100 mg tablets) of E7050 under fasted conditions. |
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| Part B: E7050 400 mg tablet under fasted conditions | Experimental | Participants will receive a single dose of 400 mg (four 100 mg tablets) of E7050 under fasted conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7050 | Drug | 100 mg tablet administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration) | 0 hour to 168 hours | |
| E7050 pharmacokinetic parameter: Cmax (maximum observed plasma concentration) | 0 hour to 168 hours | |
| E7050 pharmacokinetic parameter: t lag (time point immediately prior to the first quantifiable concentration) | 0 hour to 168 hours | |
| E7050 pharmacokinetic parameter: AUC 0-t (area under the plasma concentration-time profile from time 0 to the last measurable concentration) | 0 hour to 168 hours | |
| E7050 pharmacokinetic parameter: AUC 0-inf (area under the plasma concentration-time profile from time 0 to infinity) | 0 hour to 168 hours | |
| E7050 pharmacokinetic parameter: t1/2 (the terminal half-life) | 0 hour to 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants as a measure of adverse events (AEs) and serious adverse events (SAEs) | Up to 9 weeks |
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Inclusion criteria:
Subjects must meet all of the following criteria to be included in this study:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlarne | Netherlands |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 16, 2017 | |
| Unrelease | Yes | |
| Release | Feb 28, 2017 | |
| Reset | Apr 10, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 16, 2017 | Yes | |||
| Feb 28, 2017 |
| ID | Term |
|---|---|
| C548173 | N-(2-fluoro-4-((2-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)carbonylaminopyridin-4-yl)oxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide |
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| Apr 10, 2017 |