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

Toray Industries, Inc23 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uremic Pruritus

Interventions

TRK-820DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Bulgaria

Bulgaria, Bulgaria

Germany

Germany, Germany

Outcomes

Primary Outcomes

Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)

Time frame: 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)