Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/24/2017 |
| Start Date: | January 2014 |
| End Date: | June 2014 |
Prevention of Baclofen Withdrawal Syndrome: 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.
This study is a non-randomized dose escalation study. Three subjects will receive 10 mg doses
of IV baclofen, two or more days later the next three subjects will receive 15 mg baclofen
intravenously, and two or more days later the last three subjects will receive 20 mg IV
baclofen.
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.
higher doses of intravenous baclofen in healthy subjects.
This study is a non-randomized dose escalation study. Three subjects will receive 10 mg doses
of IV baclofen, two or more days later the next three subjects will receive 15 mg baclofen
intravenously, and two or more days later the last three subjects will receive 20 mg IV
baclofen.
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.
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).
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