A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707

Study Overview
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Brief Summary
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Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are collected until at least 144 hours after dosing.

Detailed Description
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Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if sufficient recovery of administered radioactivity is achieved, or the total excretion (urine + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour intervals. If these conditions are not met, the residential period may be prolonged for a maximum of 3 days. If after this time one of the conditions is still not met, subjects are requested to continue collecting their urine and/or feces at home for another 2 days. If after these additional 2 days one of the conditions is still not met, the condition of recovery of radioactivity is disregarded. Therefore only the total excretion condition is to be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If the excretion condition is still not met after this time, no further samples are collected and the subject is discharged from the study.

Official Title
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An Open Label Study to Evaluate the Pharmacokinetics of ASP1707 After a Single Oral Dose of 14C-labeled ASP1707 in Healthy Male Subjects

Conditions
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Pharmacokinetics of ASP1707

Intervention / Treatment
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* Drug: 14C-labeled ASP1707


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be surgically sterilized and use condoms or must practice an effective contraceptive method to prevent pregnancies. Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2. Regular defecation pattern (minimum once per day). Exclusion Criteria: Any of the liver function tests above the upper limit of normal. 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. Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit. History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit. Donation of blood or blood products within 3 months prior to admission to the Clinical Unit. Positive serology test for Hepatitis B Surface Antigen (HBsAg), anti Hepatitis A Virus (HAV) Immunoglobulin M (IgM), anti Hepatitis C Virus (HCV) or anti Human Immunodeficiency Virus (HIV) 1+2.

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: 1: ASP1707<br> | Drug: 14C-labeled ASP1707<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf) |  | Day -1 until at least Day 7 | 
| Radioactivity in whole blood measured by Area under the plasma concentration - time curve to the last quantifiable concentration (AUClast) |  | Day -1 until at least Day 7 | 
| Radioactivity in whole blood measured by Maximum concentration (Cmax) |  | Day -1 until at least Day 7 | 
| Radioactivity in whole blood measured by Time to Attain Cmax (tmax) |  | Day -1 until at least Day 7 | 
| Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2) |  | Day -1 until at least Day 7 | 
| Radioactivity in whole blood measured by Apparent total body clearance (CL/F) |  | Day -1 until at least Day 7 | 
| Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F) |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by AUCinf |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by AUClast |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by Cmax |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by tmax |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by t1/2 |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by CL/F |  | Day -1 until at least Day 7 | 
| Radioactivity in plasma measured by Vz/F |  | Day -1 until at least Day 7 | 
| Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC) |  | Day -1 until at least Day 7 | 
| Excretion rate and cumulative excretion of radioactivity in urine |  | Day -1 until at least Day 7 | 
| Excretion rate and cumulative excretion of radioactivity in feces |  | Day -1 until at least Day 7 | 
| Total cumulative excretion of radioactivity in urine and feces |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by AUCinf |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by AUClast |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by Cmax |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by tmax |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by t1/2 |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by CL/F |  | Day -1 until at least Day 7 | 
| ASP1707 in plasma measured by Vz/F |  | Day -1 until at least Day 7 | 
| ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf) |  | Day -1 until at least Day 7 | 
| ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast) |  | Day -1 until at least Day 7 | 
| ASP1707 in urine measured by Renal Clearance (CLR) |  | Day -1 until at least Day 7 | 
| ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%) |  | Day -1 until at least Day 7 | 
| ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %) |  | Day -1 until at least Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profiling of metabolites in plasma, urine and feces | This will be done separately from this study and will be reported in a separate report | Day -1 until at least Day 7 | 
| Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination |  | Screening to ESV (up to Day 40) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy subjects, Excretion, 14C-labeled ASP1707