NCT06658964

Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects

A Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Jemincare · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.

Conditions

• ADPKD (autosomal Dominant Polycystic Kidney Disease)

Interventions

Type	Name	Description
DRUG	Cohort 1: JMKX003142 and itraconazole	JMKX003142: Dose: 3 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg itraconazole once: Day8, once only in the morning. Itraconazole：Dose: 200mg once；Day5-Day7 and Day9-Day11, QD
DRUG	Cohort 2: JMKX003142 and rifampicin	JMKX003142: Dose: 6 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg rifampicin once: Day14, once only in the morning. Rifampicin：Dose: 600mg once；Day5-Day13 and Day15-Day17, QD

Timeline

• Start date: 2024-11-05
• Primary completion: 2024-12-10
• Completion: 2025-03-21
• First posted: 2024-10-26
• Last updated: 2024-10-26