Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004526-10 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.
This is an open-label, one-period, single-dose study with 14C labeled ASP3652.
Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.
On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.
The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C labeled ASP3652 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3652 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity in plasma | area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½) | Days 1 to 6 and up to Day 9 |
| Total radioactivity in whole blood | area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½) | Days 1 to 6 and up to Day 9 |
| Radioactivity ratio of plasma / blood | ratio concentrations per time point and AUC | Days 1 to 6 and up to Day 9 |
| Radioactivity excretion in urine | excretion rate and cumulative excretion | Urine: Days 1-6 and up to Day 25 |
| Radioactivity excretion in feces | excretion rate and cumulative excretion | Days 1-6 and up to Day 25 |
| Radioactivity excretion in urine and feces | excretion rate and cumulative excretion | Urine: Days 1-6 and up to Day 25 |
| ASP3652 in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after a single dose | Vital signs, 12-lead ECG, safety laboratory tests, physical examination, occurrence of Adverse Events (AE) | Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Ltd. | Leeds | LS2 9LH | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
AUCinf, AUClast, Cmax, tmax, t1/2, apparent clearance after oral administration at steady state (CL/F), volume of terminal phase distribution at steady state (Vz/F)
| Days 1 to 6 and up to Day 9 |
| ASP3652 in urine | cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf), cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast), renal clearance of the drug from plasma (CLR), percentage of unchanged drug excreted into the urine from time zero to infinity after single dose % of dose excreted (Aeinf%), percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%) | Days 1-6 and up to Day 25 |
| Ratio ASP3652 to 14C-radioactivity for AUCinf | area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf) | Days 1 to 6 and up to Day 9 |
| ID | Term |
|---|---|
| C000719587 | ASP3652 |
Not provided
Not provided
Not provided