A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to determine the effect of repeat oral doses of
eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the
pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This
will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects. The
study will comprise a screening period (between Day -45 and Day -2), treatment period 1 (Day
-1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day 24 ±
1). There will be a 10-day washout between dosing of study drug in Period 1 and Period 2. The
duration of each subject's participation in the study, inclusive of the screening and
follow-up visits, will be approximately 10 weeks.