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Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis

Anemia of Chronic Kidney Disease Clinical Trial

Official title:
A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis

Clinical Trial Summary

A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02805244
Study type Interventional
Source Akros Pharma Inc.
Contact
Status Completed
Phase Phase 1
Start date June 2016
Completion date September 2016
View Details
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