Safety Study of TRK-820 for Patient With Hemodialysis (TRK-820)

November 24, 2010 updated by: SK Chemicals Co., Ltd.

A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis

The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
  • Patients aged 20 years or older
  • Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 ~ 130 %
  • Patients who can understand and follow instructions and participate in the study during the entire study period
  • Patients who signed the informed consent form before participating in the study

Exclusion Criteria:

  • Patients who have confirmed malignant tumor
  • Patients with cognitive impairment including depression, schizophrenia and dementia
  • Patients with hepatic cirrhosis as a complication
  • Patients with drug allergy to opioids
  • Patients with drug dependency or allergic disease (including skin response to UV radiation)
  • Patients who participated in other study and received the investigational drug within 1 month before the signing day
  • Patients who participated in other TRK-820 study within 4 weeks before the signing day
  • Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception

  • Patients who received any of the following drugs within 2 weeks before Day 1

    1. Azole antifungal agents

      1. Ketoconazole
      2. Fluconazole
      3. Itraconazole
      4. Clotrimazole

    2. Macrolide antibiotics

      1. Erythromycin
      2. Midecamycin
      3. Josamycin
      4. Roxithromycin
      5. Clarithromycin
      6. Triacetyloleandomycin
    3. Ritonavir
    4. Cyclosporine
    5. Nifedipine
    6. Cimetidine
    7. Amiodarone

  • Patients who had the following drinks and foods within 2 weeks before Day 1

    1. Foods and drinks containing grape fruit juice
    2. Food and drinks containing St. John's wort
  • Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
  • Patients who smoked and drank from three months before the signing day
  • Patients who are ineligible for the clinical study for other reasons at the investigator's discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TRK-820 5 μg
Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route
Drug: nalfurafine hydrochloride
Active Comparator: TRK-820 2.5μg
Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route
Drug: nalfurafine hydrochloride

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Collaborators

Toray Industries, Inc

Investigators

  • Principal Investigator: Wooseong Huh, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2010

Last Update Submitted That Met QC Criteria

November 24, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRK-820_HD_I_2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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