Clinical trial NCT03002233: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uremic Pruritus
Keywords: TRK-820
Hemodialysis
Uremic Pruritus
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
timeFrame: Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
measure: Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
timeFrame: Part A; 24 hours postdose, Part B; 24 hours postdose each dose
measure: Pharmacokinetic parameters: apparent total clearance(CL/F)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: terminal elimination rate(λz)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: apparent distribution volume(Vz/F)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: mean residence time(MRT)
timeFrame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
timeFrame: Part B only; Baseline to week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Bulgaria
country: Bulgaria
facility: Bulgaria
city: Germany
country: Germany
facility: Germany
Study officials:
References: