SP2086 Pharmacokinetic Study in Renal Insufficiency Patients

NCT02815774 | Completed Phase 1

• 1 other identifier: HR-SP2086-Ih
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Insufficiency

Keywords

SP2086; Renal Insufficiency; Pharmacokinetic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• The number of volunteers with adverse events as a measure of safety and tolerability

  up to 96 hours

Study Arms (5)

health volunteers

ACTIVE COMPARATOR

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

Drug: SP2086

mild renal insufficiency

ACTIVE COMPARATOR

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

Drug: SP2086

moderate renal insufficiency

ACTIVE COMPARATOR

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

Drug: SP2086

severe renal insufficiency

ACTIVE COMPARATOR

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

Drug: SP2086

end-stage renal insufficiency

ACTIVE COMPARATOR

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

Drug: SP2086

Interventions

SP2086 DRUG

all subjects were given SP2086 50mg only one time.

end-stage renal insufficiency; health volunteers; mild renal insufficiency; moderate renal insufficiency; severe renal insufficiency

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jia Miao, P.H.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 28, 2016

Record last verified: 2016-06