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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03002233
• Date of registration: 13/12/2016
• Prospective Registration: No
• Primary sponsor: Toray Industries, Inc
• Public title: TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
• Scientific 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
• Date of first enrolment: November 2016
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03002233
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Bulgaria, Germany

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Uremic Pruritus

Intervention(s)

Drug: TRK-820

Primary Outcome(s)

Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline [Time Frame: Part B only; Baseline to week 5]

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]

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]

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]

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]

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]

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]

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]

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]

Pharmacokinetic parameters: mean residence time(MRT) [Time Frame: 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) [Time Frame: Part A; 24 hours postdose, Part B; 24 hours postdose each dose]

Pharmacokinetic parameters: terminal elimination rate(?z) [Time Frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose]

Secondary ID(s)

EU820UPC01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors