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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Uremic Pruritus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRK-820

PartA: 5 μg PartB: 2.5-10 μg

Group Type EXPERIMENTAL

TRK-820

Intervention Type DRUG

Interventions

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TRK-820

Intervention Type DRUG

Other Intervention Names

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Nalfurafine Hydrochloride

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No