Safety Study of TRK-820 for Patient Wit… | Clinical Trial

Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nalfurafine hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Collaborators

Toray Industries, Inc

Registry information

Official study title

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

Acronym: TRK-820

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Nov 25, 2010
Registry last updated: Nov 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed