Back to resultsA Study to Evaluate the DDI of HSK7653 With Metformin
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HSK7653
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Age ≥18 and Age ≤60 years BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index) Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures. Exclusion Criteria: Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening; Fasting blood glucose <3.9mmol/L or ≥6.1mmol/L; Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug; Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV); Treatment with an investigational drug within 3 months; Other protocol-defined exclusion criteria.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HSK7653 and Metformin
Arm Description
Outcomes
Primary Outcome Measures
The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
Secondary Outcome Measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated
Full Information
NCT ID
NCT06084156
First Posted
September 24, 2023
Last Updated
October 10, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06084156
Brief Title
A Study to Evaluate the DDI of HSK7653 With Metformin
Official Title
A Phase I Clinical Study to Evaluate the Drug-Drug Interaction Between HSK7653 and Metformin in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSK7653 and Metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HSK7653
Intervention Description
Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID
Primary Outcome Measure Information:
Title
The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
Time Frame
Day4, day 27 and day 41
Title
The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
Time Frame
Day4, day 27 and day 41
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame
First dose of study drug up to 62 days after last dose of study drug
Title
Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated
Time Frame
Day 41
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥18 and Age ≤60 years
BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.
Exclusion Criteria:
Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;
Fasting blood glucose <3.9mmol/L or ≥6.1mmol/L;
Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);
Treatment with an investigational drug within 3 months;
Other protocol-defined exclusion criteria.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the DDI of HSK7653 With Metformin
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