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Safety Study of TRK-820 for Patient With Hemodialysis

Sponsor
SK Chemicals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01248650
Collaborator
Toray Industries, Inc (Industry)
16
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: nalfurafine hydrochloride
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    2. Ketoconazole

    3. Fluconazole

    4. Itraconazole

    5. Clotrimazole

    6. Macrolide antibiotics

    7. Erythromycin

    8. Midecamycin

    9. Josamycin

    10. Roxithromycin

    11. Clarithromycin

    12. Triacetyloleandomycin

    13. Ritonavir

    14. Cyclosporine

    15. Nifedipine

    16. Cimetidine

    17. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • SK Chemicals Co., Ltd.
    • Toray Industries, Inc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01248650
    Other Study ID Numbers:
    • TRK-820_HD_I_2008
    First Posted:
    Nov 25, 2010
    Last Update Posted:
    Nov 25, 2010
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    Safety evaluation
    Pharmacokinetic analysis
    Additional relevant MeSH terms:
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Nov 25, 2010