Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRK-820 | Experimental | PartA: 5 μg PartB: 2.5-10 μg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRK-820 | Drug |
|
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bulgaria | Bulgaria | Bulgaria | ||||
| Germany |
Not provided
| ID | Term |
|---|---|
| C111212 | TRK 820 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Germany |
| Germany |