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

Study Overview
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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).

Official Title
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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

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Drug: TRK-820


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRK-820<br>PartA: 5 μg PartB: 2.5-10 μg | Drug: TRK-820<br> <br> * Other names: Nalfurafine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TRK-820, Hemodialysis, Uremic Pruritus