NCT03159832

Brief Summary

The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 19, 2017

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

May 17, 2017

Last Update Submit

May 17, 2017

Conditions

Renal Insufficiency,Type 2 Diabetes

Keywords

EfficacyPK/PD studyRenal InsufficiencyType 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • The area under the plasma concentration-time curve (AUC) of SHR3824

    AUC (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients

    72 hours after dosing

  • The maximum plasma concentration (Cmax) of SHR3824

    Cmax (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients

    72 hours after dosing

Secondary Outcomes (1)

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

    72 hours after dosing

Study Arms (3)

Normal renal function

ACTIVE COMPARATOR

All subjects were given SHR3824 20mg only one time.

Drug: SHR3824

Mild renal dysfunction

ACTIVE COMPARATOR

All subjects were given SHR3824 20mg only one time.

Drug: SHR3824

Moderate renal dysfunction

ACTIVE COMPARATOR

All subjects were given SHR3824 20mg only one time.

Drug: SHR3824

Interventions

SHR3824DRUG

All subjects were given SHR3824 20mg only one time.

Mild renal dysfunctionModerate renal dysfunctionNormal renal function

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with a body mass index(BMI) between 19 and 33 Kg/m2;
  • The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2.
  • Had signed the informed consent himself or herself voluntarily.

You may not qualify if:

  • Urinary tract infections, or vulvovaginal mycotic infections
  • Suspected or diagnosed as kidney cancer or other malignancies in patients
  • Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated
  • History of or current clinically significant medical illness as determined by the Investigator
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
  • Known allergy to SHR3824,SGLT2 inhibitor analogs, or any other structural analogs
  • 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.
  • Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
  • Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese people's liberation army general hospital of Chengdu military area

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Renal InsufficiencyDiabetes Mellitus, Type 2

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Haiyan Liu, Phd

CONTACT

+86-15705155025

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

May 17, 2017

First Posted

May 19, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 19, 2017

Record last verified: 2016-06

Locations

CN(1)