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NOT YET RECRUITING
NCT07894679
PHASE1

Effect of Itraconazole on the Pharmacokinetics of Intravenous HRS-4642 in Healthy Participants

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This is a Phase 1, single-center, open-label study designed to evaluate the effect of itraconazole on the pharmacokinetics of HRS-4642 in healthy adult participants. Approximately 18 healthy participants will be enrolled. Each participant will receive HRS-4642 alone by intravenous infusion, followed by HRS-4642 in combination with oral itraconazole. Blood samples will be collected to measure HRS-4642 concentrations and assess whether itraconazole affects how HRS-4642 is processed by the body. The safety of HRS-4642 administered alone and in combination with itraconazole will also be evaluated throughout the study.

Official title: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Injection Following Intravenous Infusion in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-10

Completion Date

2026-11

Last Updated

2026-10-26

Healthy Volunteers

Yes

Interventions

DRUG

HRS-4642

HRS-4642 injection will be administered at a dose of 200 mg by intravenous infusion on Day 1 and Day 21. The recommended infusion duration is 100 ± 10 minutes, including flushing.

DRUG

Itraconazole (200 mg)

Itraconazole capsules will be administered orally at a dose of 200 mg once daily after breakfast from Day 18 through Day 36, for a total of 19 days. On Day 21, HRS-4642 will be administered by intravenous infusion within 10 minutes after oral administration of itraconazole.