A Study to Evaluate the DDI of HSK7653 With Metformin

Haisco Pharmaceutical Group Co., Ltd.22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

HSK7653DRUG

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

MetforminDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

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 Outcomes

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

Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated

Time frame: Day 41

Data from ClinicalTrials.gov

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