Overview

A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age, body mass index [BMI], and gender).
Phase:
Phase 1
Details
Lead Sponsor:
Marathon Pharmaceuticals, LLC
PTC Therapeutics
Treatments:
Deflazacort