TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
Primary Purpose
Uremic Pruritus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TRK-820
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus focused on measuring TRK-820, Hemodialysis, Uremic Pruritus
Eligibility Criteria
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)
Sites / Locations
- Bulgaria
- Germany
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRK-820
Arm Description
PartA: 5 μg PartB: 2.5-10 μg
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
Pharmacokinetic parameters: apparent total clearance(CL/F)
Pharmacokinetic parameters: terminal elimination rate(λz)
Pharmacokinetic parameters: apparent distribution volume(Vz/F)
Pharmacokinetic parameters: mean residence time(MRT)
Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03002233
Brief Title
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
TRK-820, Hemodialysis, Uremic Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRK-820
Arm Type
Experimental
Arm Description
PartA: 5 μg PartB: 2.5-10 μg
Intervention Type
Drug
Intervention Name(s)
TRK-820
Other Intervention Name(s)
Nalfurafine Hydrochloride
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
Time Frame
Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
Title
Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
Time Frame
Part A; 24 hours postdose, Part B; 24 hours postdose each dose
Title
Pharmacokinetic parameters: apparent total clearance(CL/F)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: terminal elimination rate(λz)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: apparent distribution volume(Vz/F)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacokinetic parameters: mean residence time(MRT)
Time Frame
Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Title
Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
Time Frame
Part B only; Baseline to week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Bulgaria
City
Bulgaria
Country
Bulgaria
Facility Name
Germany
City
Germany
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
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