drugset / Trial / NCT01405599

Evaluation of the Pharmacokinetics of Ulimorelin in Subjects With Hepatic Impairment and Healthy Subjects

NCT01405599

Phase 1 Completed 32 enrolled Norgine
RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a single intravenous (IV) dose in order to identify potential patients at risks in terms of severity of hepatic dysfunction and to determine whether their dosage should be adjusted.

Timeline

Start
2011-06
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulimorelin Small molecule 480 ug/kg Intravenous