SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

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

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

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency
• Intervention / Treatment: Drug: SP2086

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: health volunteers; this group patients were given SP2086 50mg only one time.	Drug: SP2086; all subjects were given SP2086 50mg only one time.
Active Comparator: mild renal insufficiency; this group patients were given SP2086 50mg only one time.	Drug: SP2086; all subjects were given SP2086 50mg only one time.
Active Comparator: moderate renal insufficiency; this group patients were given SP2086 50mg only one time.	Drug: SP2086; all subjects were given SP2086 50mg only one time.
Active Comparator: severe renal insufficiency; this group patients were given SP2086 50mg only one time.	Drug: SP2086; all subjects were given SP2086 50mg only one time.
Active Comparator: end-stage renal insufficiency; this group patients were given SP2086 50mg only one time.	Drug: SP2086; all subjects were given SP2086 50mg only one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability	up to 96 hours

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Jia Miao, P.H.D, West China Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 3, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Renal Insufficiency; Pharmacokinetic; SP2086
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: HR-SP2086-Ih