A Study to Evaluate the DDI of HSK7653 With Metformin

NCT06084156 | Completed Phase 1

• 1 other identifier: HSK7653-102
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

HSK7653 and Metformin

EXPERIMENTAL

Drug: HSK7653; Drug: Metformin

Interventions

HSK7653 DRUG

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

HSK7653 and Metformin

Metformin DRUG

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

HSK7653 and Metformin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 16, 2023
• Study Start: August 10, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: October 16, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)