Hepatic Impairment Clinical Trial
Official title:
A Single Dose Evaluation of the Effects of Moderate (Child-Pugh Grade B) Hepatic Impairment on Deflazacort Pharmacokinetics
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).
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).
On Day 1, a single oral dose of deflazacort will be administered followed by serial blood
sampling for 24 hours to assess the PK of 21-desacetyl-DFZ and, if data permits, deflazacort.
Safety will be monitored throughout the study by repeated clinical and laboratory
evaluations.
Subjects will return to the Clinical Research Unit (CRU) 3 days (± 1 day) following study
drug administration to determine if any adverse events (AEs) have occurred since the last
study visit. Subjects who terminate the study early will be contacted if the Principal
Investigator (PI) deems necessary.
A total of sixteen (16) adult male and female subjects will be enrolled. Hepatic Impaired
Cohort: Eight (8) subjects with moderate hepatic insufficiency (a score of 7 to 9, on the
Child-Pugh scale).
Healthy Match Control Cohort: Eight (8) healthy subjects. Subjects will be matched for age [±
15 years], BMI [± 15 %], and gender [1:1] to the subjects in the moderate hepatic impaired
cohort.
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