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drugset / Trial / NCT06589635

A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects

NCT06589635 ↗

Phase 1 Completed 16 enrolled Jiaxing AnDiCon Biotech Co.,Ltd
NaSequentialOpen-labelTreatment

Summary

This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults. Participants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.

Timeline

Start
2024-07-16
Primary completion
2024-09-11
Completion
2024-09-11

Drugs

EvaluationDrugModalityDoseRoute
Subject ADC189 Unknown 45 mg Oral
Subject Itraconazole Small molecule 200 mg Oral

Indications

No indication recorded.