A DDI Study of JMKX000623 and Metformin Hydrochloride

Phase 1

Completed

• Conditions: Healthy; Drug-Drug Interaction
• Interventions: Drug: JMKX000623; Drug: Metformin

• Registration Number: NCT06066060
• Lead Sponsor: Jemincare

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-09-13
• Study Start: 2023-09-17
• Study First Submitted QC: 2023-09-30
• Study First Posted: 2023-10-04
• Primary Completion: 2023-11-06
• Study Completion: 2023-11-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JMKX000623/Metformin/ JMKX000623+Metformin	JMKX000623	D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin
JMKX000623/Metformin/ JMKX000623+Metformin	Metformin	D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events (AEs)	baseline through 4 days post-dose	Incidence and features of AEs assessed by CTCAE v5.0.

Trial Locations

Locations (1)

Huashan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China