Safety Study of TRK-820 for Patient With Hemodialysis

NCT01248650 | Completed Phase 1

• 1 other identifier: TRK-820_HD_I_2008
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Renal Failure

Keywords

Safety evaluation; Pharmacokinetic analysis

Study Arms (2)

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

Drug: nalfurafine hydrochloride

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

Drug: nalfurafine hydrochloride

Interventions

nalfurafine hydrochloride DRUG

TRK-820 2.5μg; TRK-820 5 μg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead
• Toray Industries, Inc: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

TRK 820

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wooseong Huh, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 25, 2010
• Study Start: December 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 25, 2010

Record last verified: 2009-11

Locations

KR (1)