Safety Study of TRK-820 for Patient With Hemodialysis

Chronic Renal Failure Clinical Trial

— TRK-820  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248650
• Other study ID #: TRK-820_HD_I_2008
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2010
• Last updated: November 24, 2010
• Start date: December 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2009
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

1. Ketoconazole

2. Fluconazole

3. Itraconazole

4. Clotrimazole

2. Macrolide antibiotics

1. Erythromycin

2. Midecamycin

3. Josamycin

4. Roxithromycin

5. Clarithromycin

6. Triacetyloleandomycin

3. Ritonavir

4. Cyclosporine

5. Nifedipine

6. Cimetidine

7. 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• nalfurafine hydrochloride

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.	Toray Industries, Inc

Country where clinical trial is conducted

Korea, Republic of,