SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

Renal Insufficiency Clinical Trial

Official title:

A Parallel, Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815774
• Other study ID #: HR-SP2086-Ih
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2016
• Last updated: June 23, 2016
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.

Description:

This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• with a body mass index(BMI) between 19 and 28 Kg/m2;Weight:=50Kg(male),=45kg(female)

• The endogenous creatinine clearance of subjects in groups must meet the standards of Ccr in renal function in installment:mild renal insufficiency:60-89 - ml/min;Moderate renal insufficiency: 30 to 59 ml/min;Severe renal insufficiency: 15-29 ml/min;End-stage renal disease: < 15 ml/min.Normal renal function: 90 ml/min or more.

• Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

• Cannot tolerate oral medicine.

• Not control or unstable cardiovascular, respiratory, liver, digestive, endocrine, hematopoietic, the mental or nerve system diseases.

• Had the digestive surgery that could affect drug absorption.

• The clinical significance of arrhythmia.

• Acute hepatitis, chronic liver disease; ALT or AST value was 2 times greater than upper normal limit, Total bilirubin value was 1.5 times greater than upper normal limit.

• HBV surface antigen, HCV antibody, or HIV antibody was positive.

• history of drug allergy or allergic constitution or family history of allergy.

• Had Used hormonal contraception within 3 months;

• Had Used DPP - IV inhibitor within 2 weeks;

• Had Used traditional Chinese medicine (Chinese herbs, Chinese patent medicine) within 2 weeks;

• Had Used acid inhibitors within 2 weeks;

• Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.

• 2 days before the randomization till to the end ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion

• The patient had participated three times or more clinical trial in one year, or one time within 3 months.

• Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.

• History of blood donation or participate in blood donation, or by blood transfusion in 3 months prior to screening.

• Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Study Design

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• SP2086
all subjects were given SP2086 50mg only one time.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum plasma concentration (Cmax) of SP2086	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086	up to 96 hours	No
Primary	The maximum plasma concentration (Cmax) of SP2086 acid	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086	up to 96 hours	No
Primary	The area under the plasma concentration-time curve (AUC) of SP2086	AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086	up to 96 hours	No
Primary	The area under the plasma concentration-time curve (AUC) of SP2086 acid	AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086	up to 96 hours	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to 96 hours	Yes