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Safety and Pharmacokinetics of Intravenous Baclofen | Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers

Safety and Pharmacokinetics of Intravenous Baclofen research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Safety and Pharmacokinetics of Intravenous Baclofen

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intravenous baclofen

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intravenous BaclofenThree 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.

Study Status

Completed

Start Date: January 2014

Completed Date: June 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Safety assessments

Secondary Outcome: Maximum Concentration(Cmax)

Study sponsors, principal investigator, and references

Principal Investigator: Robert L Kriel, MD

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator: Paralyzed Veterans of America Research Foundation

More information:https://clinicaltrials.gov/show/NCT01931319

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