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NCT01931319 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01931319 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 39 participants.
The verdict
NCT01931319, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study 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.
Interventions
- DRUG Intravenous baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01931319
The ClinicalTrials.gov registry entry for NCT01931319 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intravenous baclofen is the first listed.
NCT01931319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01931319 about?
NCT01931319 is a clinical study titled "Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers". 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 respe...
What is the current status of trial NCT01931319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01931319?
The interventions under investigation include: Intravenous baclofen (DRUG).
Who is sponsoring clinical trial NCT01931319?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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