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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03002233
Other study ID # EU820UPC01
Secondary ID
Status Completed
Phase Phase 1
First received December 13, 2016
Last updated July 19, 2017
Start date November 2016
Est. completion date July 2017

Study information

Verified date July 2017
Source Toray Industries, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
TRK-820


Locations

Country Name City State
Bulgaria Bulgaria Bulgaria
Germany Germany Germany

Sponsors (1)

Lead Sponsor Collaborator
Toray Industries, Inc

Countries where clinical trial is conducted

Bulgaria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Pharmacokinetic parameters: maximum observed plasma concentration (Cmax) Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary Pharmacokinetic parameters: time to maximum plasma concentration(Tmax) Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary 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
Primary Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h) Part A; 24 hours postdose, Part B; 24 hours postdose each dose
Primary Pharmacokinetic parameters: apparent total clearance(CL/F) Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary Pharmacokinetic parameters: terminal elimination rate(?z) Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary Pharmacokinetic parameters: apparent distribution volume(Vz/F) Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary Pharmacokinetic parameters: mean residence time(MRT) Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Primary Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline Part B only; Baseline to week 5
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