A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects

Conditions
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Healthy Subjects, Pharmacokinetics of ASP3652

Intervention / Treatment
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* Drug: ASP3652


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is white and of Caucasian origin. Regular defecation pattern (minimum once per day). Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy. Exclusion Criteria: Known or suspected hypersensitivity to ASP3652 or any components of the formulation used. Donation of blood or blood products within 3 months prior to admission to the Clinical Unit. Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C labeled ASP3652<br> | Drug: ASP3652<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, ASP3652, 14C radio-labeled, Phase 1