A Study to Evaluate the DDI of HSK7653 With Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase I Clinical Study to Evaluate the Drug-Drug Interaction Between HSK7653 and Metformin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06084156
• Other study ID #: HSK7653-102
• Status: Completed
• Phase: Phase 1
• Start date: August 10, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: September 2023
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HSK7653
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
• Metformin
Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.		Day4, day 27 and day 41
Primary	The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.		Day4, day 27 and day 41
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		First dose of study drug up to 62 days after last dose of study drug
Secondary	Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated		Day 41