Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Paralyzed Veterans of America Research Foundation
• Treatments: Baclofen

Criteria

Inclusion Criteria:

1. Males and females between the ages of 18-65.

2. Subjects are capable of giving informed consent.

3. Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.

4. Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

Exclusion Criteria:

1. Women who are pregnant.

2. Women who are breastfeeding.

3. Subject has a history of intolerance to IV administration of medication.

4. Subject has a known hypersensitivity to baclofen.

5. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease

6. Subject has taken or used any investigational drug or device in the 30 days prior to screening.

7. Subject has taken either prescribed or over the counter medication for 48 hours prior to baclofen administration on either of the study days, other than hormonal birth control.

8. Subject reveals clinically significant abnormalities on screening laboratory tests.

9. Subject is a non-English speaker, such that ability to ascertain neurological status would require an interpreter.

10. Sleep deprivation (for example. working the night shift the evening prior to the study).