drugset / Trial / NCT03103568

A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers

NCT03103568

Phase 1 Completed 36 enrolled Swedish Orphan Biovitrum Parexel · collab
Non-randomizedSequentialOpen-labelBasic science

Summary

An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion transporters OAT1 and OAT3 in healthy volunteers

Timeline

Start
2017-03-28
Primary completion
2017-06-10
Completion
2017-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorzoxazone Small molecule 250 mg Oral
Subject Furosemide Other / unclassified 20 mg Intravenous
Subject Metoprolol Other / unclassified 50 mg Oral
Subject Nitisinone Small molecule 80 mg Oral
Subject Tolbutamide Small molecule 500 mg Oral

Indications

No indication recorded.