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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03002233

Enrollment

Registered

2016-12-23

Start date

2016-11-30

Completion date

2017-07-31

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremic Pruritus

Keywords

TRK-820, Hemodialysis, Uremic Pruritus

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).

Interventions

DRUGTRK-820

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Countries

Bulgaria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026