SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

Hengrui Medicine

Status and phase

Completed

Phase 1

Conditions

Renal Insufficiency

Treatments

Drug: SP2086

Study type

Interventional

Funder types

Industry

Identifiers

NCT02815774

HR-SP2086-Ih

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 5 patient groups

health volunteers

Active Comparator group

Description: