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

NCT03002233 | Completed Phase 1

• 1 other identifier: EU820UPC01
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

TRK-820; Hemodialysis; Uremic Pruritus

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)

  Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

• Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)

  Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

• 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

• Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)

  Part A; 24 hours postdose, Part B; 24 hours postdose each dose

• Pharmacokinetic parameters: apparent total clearance(CL/F)

  Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

• Pharmacokinetic parameters: terminal elimination rate(λz)

  Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

• Pharmacokinetic parameters: apparent distribution volume(Vz/F)

  Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

• Pharmacokinetic parameters: mean residence time(MRT)

  Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

• Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline

  Part B only; Baseline to week 5

Study Arms (1)

TRK-820

EXPERIMENTAL

PartA: 5 μg PartB: 2.5-10 μg

Drug: TRK-820

Interventions

TRK-820 DRUG

Also known as: Nalfurafine Hydrochloride

TRK-820

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (2)

Bulgaria

Bulgaria, Bulgaria

Location

Germany

Germany, Germany

Location

MeSH Terms

Interventions

TRK 820

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 23, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

BU (1); DE (1)