Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult
subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with
moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic
impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function with
mean age, body mass index (BMI), and gender distribution targeted to be similar to the
impaired hepatic function cohorts.