drugset / Trial / NCT05391724

Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects

NCT05391724

Phase 1 Completed 25 enrolled Jazz Pharmaceuticals
NaSingle-groupOpen-labelOther

Summary

This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe hepatic impairment.

Timeline

Start
2011-02
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Brincidofovir Other / unclassified 2 mg/kg Oral

Indications

No indication recorded.