drugset / Trial / NCT04200573

Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855

NCT04200573

Phase 1 Completed 31 enrolled Theravance Biopharma
Non-randomizedParallel-groupOpen-labelTreatment

Summary

An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.

Timeline

Start
2020-01-13
Primary completion
2021-08-19
Completion
2021-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject ampreloxetine Small molecule 10 mg Oral