A DDI Study of JMKX000623 and Metformin Hydrochloride

• Sponsor: Jemincare (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06066060
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 1.1
• Patients Per Site Per Month: 21.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Drug-Drug Interaction	Drug: JMKX000623; Drug: Metformin; Drug: JMKX000623; Drug: Metformin	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
• Actual Study Start Date: Sep 17, 2023
• Anticipated Primary Completion Date: Oct 21, 2023
• Anticipated Study Completion Date: Oct 21, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: JMKX000623/Metformin/ JMKX000623+Metformin D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin

Drug: JMKX000623; JMKX000623, 200mg，administered orally once daily for 8 doses(D1-D8）; Drug: Metformin; D14-D17, Metformin, 500mg, administered orally twice daily for 7 doses(D14-D17，D17 only 1 dose at morning); Drug: JMKX000623; JMKX000623, 200mg, administered orally once daily for 8 doses(D20-D27）; Drug: Metformin; Metformin, 500mg, administered orally twice daily for 7 doses(D24-D27，D27 only 1 dose at morning);

Outcome Measures

Primary Outcome Measures

1. Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau） [baseline through 4 days post-dose]

2. Maximum observed After Reaching steady state concentration (Css,max) [baseline through 4 days post-dose]

Secondary Outcome Measures

1. Adverse events (AEs) [baseline through 4 days post-dose]

   Incidence and features of AEs assessed by CTCAE v5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital Fudan University	Shanghai	Shanghai	China

Sponsors and Collaborators

• Jemincare

Investigators

• Principal Investigator: Xiaojie Wu, MD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jemincare
• ClinicalTrials.gov Identifier: NCT06066060
• Other Study ID Numbers: JY-JM025-102
• First Posted: Oct 4, 2023
• Last Update Posted: Oct 4, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metformin

Study Results

No Results Posted as of Oct 4, 2023