NCT02106780

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Pharmacokinetics of ASP1707

Interventions

Type	Name	Description
DRUG	14C-labeled ASP1707	oral

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2014-04-08
• Last updated: 2014-04-08

Locations

1 site across 1 country: United Kingdom