NCT01248650CompletedPhase 1
A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 16
- Locations
- 1
Study Overview
Brief Summary
The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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
- •Azole antifungal agents
- •Ketoconazole
- •Fluconazole
- •Itraconazole
- •Clotrimazole
- •Macrolide antibiotics
- •Erythromycin
- •Midecamycin
- •Roxithromycin
- •Clarithromycin
- •Triacetyloleandomycin
- •Cyclosporine
- •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
Arms & Interventions
TRK-820 5 μg
Active Comparator
Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route
Intervention: nalfurafine hydrochloride (Drug)
TRK-820 2.5μg
Active Comparator
Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route
Intervention: nalfurafine hydrochloride (Drug)
Investigators
Study Sites (1)
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