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NOT YET RECRUITING
NCT07565441
PHASE1

Drug-Drug Interactions of JMKX003142 in Healthy Participants

Sponsor: Jemincare

View on ClinicalTrials.gov

Summary

This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants. The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.

Official title: A Single-center, Non-randomized, Open-label, Self-controlled, Phase I Clinical Study to Evaluate Drug-Drug Interactions (DDI) of JMKX003142 Tablets in Chinese Healthy Participants.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-05-11

Completion Date

2027-02-28

Last Updated

2026-05-04

Healthy Volunteers

Yes

Interventions

DRUG

JMKX003142 tablets

3mg once daily (QD) on Day 1 and Day 7

DRUG

Fluconazole Capsules

400mg QD on Day 4, 200mg QD from Day 5 to Day 9

DRUG

Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets)

Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21

DRUG

Cyclosporine Soft Capsules

100 mg twice daily (BID) from Day 4 to Day 9

DRUG

Omeprazole Enteric-coated Tablets

40mg QD from Day 4 to Day 8

DRUG

Efavirenz Tablets

600mg QD from Day 4 to Day 12

DRUG

JMKX003142 tablets

6mg QD from Day 8 to Day 25

DRUG

JMKX003142 tablets

6mg QD on Day 1 and Day 8

DRUG

JMKX003142 tablets

6mg QD on Day 1 and Day 10