Safety Study of TRK-820 for Patient With Hemodialysis

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

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

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Drug: nalfurafine hydrochloride


Participation Criteria
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Eligibility Criteria
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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 Azole antifungal agents Ketoconazole Fluconazole Itraconazole Clotrimazole Macrolide antibiotics Erythromycin Midecamycin Josamycin Roxithromycin Clarithromycin Triacetyloleandomycin Ritonavir Cyclosporine Nifedipine Cimetidine Amiodarone Patients who had the following drinks and foods within 2 weeks before Day 1 Foods and drinks containing grape fruit juice 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety evaluation, Pharmacokinetic analysis