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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
oral
Covance Clinical Research Unit (CRU) Ltd.
Leeds, United Kingdom
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)
Time frame: 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)
Time frame: Days 1 to 6 and up to Day 9
Radioactivity ratio of plasma / blood
ratio concentrations per time point and AUC
Time frame: Days 1 to 6 and up to Day 9
Radioactivity excretion in urine
excretion rate and cumulative excretion
Time frame: Urine: Days 1-6 and up to Day 25
Radioactivity excretion in feces
excretion rate and cumulative excretion
Time frame: Days 1-6 and up to Day 25
Radioactivity excretion in urine and feces
excretion rate and cumulative excretion
Time frame: Urine: Days 1-6 and up to Day 25
ASP3652 in plasma
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)
Time frame: Days 1 to 6 and up to Day 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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%)
Time frame: 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)
Time frame: Days 1 to 6 and up to Day 9
Safety and tolerability after a single dose
Vital signs, 12-lead ECG, safety laboratory tests, physical examination, occurrence of Adverse Events (AE)
Time frame: Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)