Back to resultsSP2086 Pharmacokinetic Study in Renal Insufficiency Patients
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SP2086
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring SP2086, Renal Insufficiency, Pharmacokinetic
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
health volunteers
mild renal insufficiency
moderate renal insufficiency
severe renal insufficiency
end-stage renal insufficiency
Arm Description
this group patients were given SP2086 50mg only one time.
this group patients were given SP2086 50mg only one time.
this group patients were given SP2086 50mg only one time.
this group patients were given SP2086 50mg only one time.
this group patients were given SP2086 50mg only one time.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
The number of volunteers with adverse events as a measure of safety and tolerability
Full Information
NCT ID
NCT02815774
First Posted
January 3, 2016
Last Updated
June 23, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02815774
Brief Title
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients
Official Title
A Parallel, Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
SP2086, Renal Insufficiency, Pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
health volunteers
Arm Type
Active Comparator
Arm Description
this group patients were given SP2086 50mg only one time.
Arm Title
mild renal insufficiency
Arm Type
Active Comparator
Arm Description
this group patients were given SP2086 50mg only one time.
Arm Title
moderate renal insufficiency
Arm Type
Active Comparator
Arm Description
this group patients were given SP2086 50mg only one time.
Arm Title
severe renal insufficiency
Arm Type
Active Comparator
Arm Description
this group patients were given SP2086 50mg only one time.
Arm Title
end-stage renal insufficiency
Arm Type
Active Comparator
Arm Description
this group patients were given SP2086 50mg only one time.
Intervention Type
Drug
Intervention Name(s)
SP2086
Intervention Description
all subjects were given SP2086 50mg only one time.
Primary Outcome Measure Information:
Title
The maximum plasma concentration (Cmax) of SP2086
Description
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
Time Frame
up to 96 hours
Title
The maximum plasma concentration (Cmax) of SP2086 acid
Description
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
Time Frame
up to 96 hours
Title
The area under the plasma concentration-time curve (AUC) of SP2086
Description
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
Time Frame
up to 96 hours
Title
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Description
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
Time Frame
up to 96 hours
Secondary Outcome Measure Information:
Title
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame
up to 96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Miao, P.H.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients
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