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

Phase 1

Completed

• Conditions: Uremic Pruritus
• Interventions: Drug: TRK-820

• Registration Number: NCT03002233
• Lead Sponsor: Toray Industries, Inc

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRK-820	TRK-820	PartA: 5 μg PartB: 2.5-10 μg

Primary Outcome Measures

Name	Time	Method
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: mean residence time(MRT)	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 to 24 hours postdose(AUC0-24h)	Part A; predose to 24 hours postdose, Part B; predose to 24 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: terminal elimination rate(λz)	Part A; predose to 60 hours postdose, Part B; predose to 48 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: apparent distribution volume(Vz/F)	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
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: 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

Trial Locations

Locations (2)

Germany; 🇩🇪 Germany, Germany

Bulgaria; 🇧🇬 Bulgaria, Bulgaria