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

Uremic Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002233
• Other study ID #: EU820UPC01
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2016
• Last updated: July 19, 2017
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult non-smoking male and female subjects (= 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.

• Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)

Exclusion Criteria:

• Subject has a known hypersensitivity to opioids or the ingredients of the study medication.

• Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• TRK-820

Locations

Country	Name	City	State
Bulgaria	Bulgaria	Bulgaria
Germany	Germany	Germany

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Countries where clinical trial is conducted

Bulgaria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)		Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
Primary	Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)		Part A; 24 hours postdose, Part B; 24 hours postdose each dose
Primary	Pharmacokinetic parameters: apparent total clearance(CL/F)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: terminal elimination rate(?z)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: apparent distribution volume(Vz/F)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacokinetic parameters: mean residence time(MRT)		Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary	Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline		Part B only; Baseline to week 5