A DDI Study of JMKX000623 and Metformin Hydrochloride

Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects

A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.

Study Overview

• Status: Completed
• Conditions: Healthy; Drug-Drug Interaction
• Intervention / Treatment: Drug: JMKX000623; Drug: Metformin

Detailed Description

The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy Chinese subjects aged 18-45 years, male or female;
2. Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2;
3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
4. Able to provide written informed consent voluntarily.

Exclusion Criteria:

1. Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
2. History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
3. Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
4. Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
5. Other conditions unsuitable for the study confirmed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JMKX000623/Metformin/ JMKX000623+Metformin; D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin	Drug: JMKX000623; JMKX000623, administered orally ; Drug: Metformin; Metformin,administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）	baseline through 4 days post-dose
Maximum observed After Reaching steady state concentration (Css,max)	baseline through 4 days post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Incidence and features of AEs assessed by CTCAE v5.0.	baseline through 4 days post-dose

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Xiaojie Wu, MD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2023
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): November 6, 2023

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: JY-JM025-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No