NCT03002233

TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus

A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a 2-part study. Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis. Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	TRK-820

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-12-23
• Last updated: 2017-07-21

Locations

2 sites across 2 countries: Bulgaria, Germany