A Study to Evaluate the DDI of HSK7653 With Metformin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06084156

Enrollment

Registered

2023-10-16

Start date

2019-08-10

Completion date

2019-12-09

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGHSK7653

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

DRUGMetformin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026