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Completed

NCT Number: NCT03002233

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

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).

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Key information

Conditions

Uremic Pruritus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TRK-820

Drug

Other names: Nalfurafine Hydrochloride

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)

    Time frame: Part A; 24 hours postdose, Part B; 24 hours postdose each dose

  8. 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

  9. Pharmacokinetic parameters: terminal elimination rate(λz)

    Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

  10. 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

  11. Pharmacokinetic parameters: mean residence time(MRT)

    Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose

  12. Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline

    Time frame: Part B only; Baseline to week 5

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2016
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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