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This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.
This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.
Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part-1 dose 1 | Experimental |
| |
| Part-1 dose 2 | Experimental |
| |
| Part-1 dose 3 | Experimental |
| |
| Part-1 dose 4 | Experimental |
| |
| Part-1 dose 5 | Experimental |
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| Part-1 dose 6 | Experimental |
| |
| Part-1 placebo | Placebo Comparator |
| |
| Part-2 fed | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7991 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs | for 96 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F | Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours | for 96 hours after dosing |
| Urinary concentrations of unchanged drug: Aelast,Aelast%, CLr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantou | Japan |
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|
| Part-2 fasted | Experimental |
|
| Placebo | Drug | oral |
|
Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours |
| for 96 hour after dosing |
| plasma parathyroid hormon concentration | Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours | for 96 hours after dosing |
| ID | Term |
|---|---|
| C000628269 | ASP7991 |
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