MedTrace Logo

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

NCT06658964 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-10-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zhejiang Hangyu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Jemincare

    lead INDUSTRY

Principal Investigators

  • Leilei Zhu · Shuguang Hospital Affiliated with Shanghai University of TCM

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2024-12-10
Completion
2025-03-21

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658964 on ClinicalTrials.gov