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| ID | Type | Description | Link |
|---|---|---|---|
| QSC203335 | Other Identifier | Quotient Sciences | |
| 2020-005638-13 | EudraCT Number |
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The primary purpose of this study is to evaluate the pharmacokinetic (PK) profile of E7386 following oral administration of E7386 enteric coated TR prototype tablet formulations (TR1, TR2 and optional TR3) and to evaluate the relative bioavailability of E7386 TR tablets compared to E7386 IR reference tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: E7386 40 mg | Experimental | Participants will be randomized to one of the 3 treatment sequences: Treatment sequence 1: Participants will receive Regimen A on Day 1 of treatment period 1 then Regimen B on Day 1 of treatment period 2 then Regimen C on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 2: Participants will receive Regimen B on Day 1 of treatment period 1 then Regimen C on Day 1 of treatment period 2 then Regimen A on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 3: Participants will receive Regimen C on Day 1 of treatment period 1 then Regimen A on Day 1 of treatment period 2 then Regimen B on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. A maximum wash out period of 10 days will be maintained between treatment periods 1, 2 and 3. |
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| Cohort 2: E7386 40 mg | Experimental | Participants will be randomized to one of the 3 treatment sequences: Treatment sequence 4: Participants will receive Regimen C on Day 1 of treatment period 1 then Regimen B on Day 1 of treatment period 2 then Regimen A on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 5: Participants will receive Regimen A on Day 1 of treatment period 1 then Regimen C on Day 1 of treatment period 2 then Regimen B on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 6: Participants will receive Regimen B on Day 1 of treatment period 1 then Regimen A on Day 1 of treatment period 2 then Regimen C on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. A maximum wash out period of 10 days will be maintained between treatment periods 1, 2 and 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7386 | Drug | Regimen A: 40 milligram (mg) IR Oral Tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for E7386 | Day 1: 0-48 hours post-dose | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386 | Day 1: 0-48 hours post-dose | |
| AUC (0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 | Day 1: 0-48 hours post-dose | |
| AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for E7386 | Day 1: 0-48 hours post-dose | |
| T1/2: Terminal Elimination Phase Half-life for E7386 | Day 1: 0-48 hours post-dose | |
| CL/F: Apparent Total Clearance Following Extravascular Administration for E7386 | Day 1: 0-48 hours post-dose | |
| Vz/F: Apparent Volume of Distribution at Terminal Phase for E7386 | Day 1: 0-48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | United Kingdom |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| C000717377 | E-7386 |
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