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| Name | Class |
|---|---|
| Kyowa Kirin China Pharmaceutical Co., Ltd. | INDUSTRY |
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The primary objective is to evaluate the pharmacokinetic profile of KHK7580 in Chinese healthy adult volunteers. The secondary objective is to evaluate its safety and pharmacodynamics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose administration of 1mg KHK7580 | Experimental |
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| Single dose administration of 3mg KHK7580 | Experimental |
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| Single dose administration of 6mg KHK7580 | Experimental |
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| Single dose administration of 12mg KHK7580 | Experimental |
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| Multiple dose administration of 6mg KHK7580 for 8days | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1mg KHK7580 | Drug | Single oral dose administration of 1mg KHK7580 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma KHK7580 concentration at each time point | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of KHK7580 | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort | |
| Maximum Observed Plasma Concentration (Cmax) of KHK7580 | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort | |
| Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t) of KHK7580 | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of KHK7580 | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort | |
| Plasma Half-Life (t1/2) of KHK7580 | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Dosing to study completion | |
| QTcF | [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12 | |
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Inclusion Criteria:
Exclusion Criteria:
Subjects must be excluded from the study if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing hospital | Beijing | Beijing Municipality | China |
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| 3mg KHK7580 | Drug | Single oral dose administration of 3mg KHK7580 |
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| 6mg KHK7580 | Drug | Single oral dose administration of 6mg KHK7580 |
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| 12mg KHK7580 | Drug | Single oral dose administration of 12mg KHK7580 |
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| 6mg KHK7580 for 8days | Drug | multiple oral dose administration of 6mg KHK7580 for 8days |
|
| Apparent systemic clearance (CL/F) of KHK7580 | pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort |
| QTcB |
| [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12 |
| intact PTH level | [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12 |
| serum P level | [Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12 |