The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Multiple Dose of SHR3824 in Healthy Subjects
1 other identifier
interventional
48
1 country
1
Brief Summary
SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Dec 2013
1 active site
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
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 11, 2015
CompletedFebruary 11, 2015
December 1, 2014
5 months
February 1, 2015
February 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
AUC(Area under the curve) of SHR3824.
day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.
day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.
day1 and day11 to day 13.
Halflife of SHR3824.
day1 and day11 to day 13.
CL/F of SHR3824.
day1 and day11 to day 13.
V/F of SHR3824.
day1 and day11 to day 13.
Accumulation ratio of SHR3824
Up to day 13.
Urine glucose concentration of SHR3824.
day1 and day11
Plasma glucose concentration of SHR3824.
day1 and day11
Secondary Outcomes (2)
Adverse events, vital signs, physical exams , ECG, clinical labs
Days -14 to -1, 0, 13.
Serum creatinine
Days -14 to -1, 0, 2, 9, 13.
Study Arms (6)
Cohort SHR3824/Placebo 1.25 mg
EXPERIMENTALSHR3824 1.25 mg/day or placebo for 10 days.
Cohort SHR3824/Placebo 2.5 mg
EXPERIMENTALSHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 5 mg
EXPERIMENTALSHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 10 mg
EXPERIMENTALSHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 25 mg
EXPERIMENTALSHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 100mg
EXPERIMENTALSHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Interventions
Eligibility Criteria
You may qualify if:
- Chinese male and female subjects aged 18 to 45 years.
- BMI:18 -25 kg/m2.
- Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.
You may not qualify if:
- 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.
- Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
- Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2015
First Posted
February 11, 2015
Study Start
December 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 11, 2015
Record last verified: 2014-12