A Study to Evaluate the DDI of HSK7653 With Metformin

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: HSK7653; Drug: Metformin

• Registration Number: NCT06084156
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-10
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Status Verified: 2023-09
• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSK7653 and Metformin	HSK7653	-
HSK7653 and Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated	Day 41
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	First dose of study drug up to 62 days after last dose of study drug

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China