Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to determine safety and characterize pharmacokinetics of
higher doses of intravenous baclofen in healthy subjects.
Thirty-six healthy adults received a single dose of PO baclofen (10mg, 15mg or 20mg) and a
10-minute infusion of IV baclofen (7.5mg, 11.5mg or 15mg respectively) with a minimum 48-hour
wash out period. Twelve subjects also received a 60-minute infusion of 15mg IV baclofen
following an additional 48-hour wash out period.
The pharmacokinetic and tolerability information gained from this study will support the
development of further studies to assess the use of IV baclofen to prevent or treat baclofen
withdrawal syndrome.
Phase:
Phase 1
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute