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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in Chinese healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A-1:MT-7117 100 mg | Active Comparator | single oral dose |
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| Cohort A-1:Placebo | Placebo Comparator | single oral dose |
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| Cohort A-2:MT-7117 300mg | Active Comparator | single oral dose |
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| Cohort A-2:Placebo | Placebo Comparator | single oral dose |
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| Cohort B-1:MT-7117 200mg | Active Comparator | single dose followed by once-daily oral dosing |
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| Cohort B-1:Placebo | Placebo Comparator | single dose followed by once-daily oral dosing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-7117 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) | |
| Time to maximum plasma concentration (tmax)of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) | |
| Apparent plasma terminal elimination half-life (t1/2) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) | |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24h) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) | |
| Area under the plasma concentration-time curve from time zero to 48 hours(AUC0-48h) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) | |
| Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-last) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Treatment-emergent Adverse events (AEs) (including serious AEs [SAEs] and hepatic AEs of special interest [AESIs]). | The time written informed consent is obtained from a subject until the end of the safety follow-up period or the withdrawal of the subject from the study (PartA), or until Day 21 or the withdrawal of the subject from the study (PartB). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China |
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| Placebo | Drug | Oral |
|
| Area under the plasma concentration-time curve over the dosing interval (AUC0-τ) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-∞). | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Terminal elimination rate constant (kel) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Apparent oral clearance (CL/F) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Apparent volume of distribution during the terminal phase after oral administration (Vz/F) of MT-7117 | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Apparent volume of distribution at steady state (Vss/F) of MT-7117 | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |
| Mean residence time (MRT) of MT-7117. | PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP) |