SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

NCT ID: NCT02815774

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

Brief Summary

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

Detailed 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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

health volunteers

this group patients were given SP2086 50mg only one time.

Group Type: ACTIVE_COMPARATOR

SP2086

Intervention Type: DRUG

all subjects were given SP2086 50mg only one time.

mild renal insufficiency

this group patients were given SP2086 50mg only one time.

Group Type: ACTIVE_COMPARATOR

SP2086

Intervention Type: DRUG

all subjects were given SP2086 50mg only one time.

moderate renal insufficiency

this group patients were given SP2086 50mg only one time.

Group Type: ACTIVE_COMPARATOR

SP2086

Intervention Type: DRUG

all subjects were given SP2086 50mg only one time.

severe renal insufficiency

this group patients were given SP2086 50mg only one time.

Group Type: ACTIVE_COMPARATOR

SP2086

Intervention Type: DRUG

all subjects were given SP2086 50mg only one time.

end-stage renal insufficiency

this group patients were given SP2086 50mg only one time.

Group Type: ACTIVE_COMPARATOR

SP2086

Intervention Type: DRUG

all subjects were given SP2086 50mg only one time.

Interventions

SP2086

all subjects were given SP2086 50mg only one time.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Miao, P.H.D

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Other Identifiers

HR-SP2086-Ih

Identifier Type: -

Identifier Source: org_study_id