drugset / Trial / NCT03366974

Assessment of Change in CYP3A Activity by Route of Administration Using Metabolic Markers in Healthy Male Volunteers

NCT03366974

Phase 1 Completed 16 enrolled Seoul National University Hospital
NaSingle-groupOpen-labelBasic science

Summary

The study objective is to evaluate and validate of endogenous markers for the assessment of change in CYP3A activity by route of administration in Korean healthy subjects using metabolomics. In addition, we aim to screen novel endogenous marker, which could determine the total or intestinal CYP activity.

Timeline

Start
2017-12-28
Primary completion
2018-02-13
Completion
2018-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg Oral
Subject Midazolam Small molecule 1 mg Intravenous
Subject Midazolam Small molecule 5 mg Intravenous

Indications

No indication recorded.