Clinical Trial: TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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).
Detailed Summary:
Sponsor: Toray Industries, Inc
Current Primary Outcome:
- 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: 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: 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: 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: 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 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: plasma concentration at 24 hours postdose(C24h) [ Time Frame: Part A; 24 hours postdose, Part B; 24 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:
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Toray Industries, Inc
Dates:
Date Received: December 13, 2016
Date Started: November 2016
Date Completion:
Last Updated: December 20, 2016
Last Verified: December 2016