Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Combination treatment with baclofen and chlorzoxazone (CHZ) is under investigation for the treatment of spinocerebellar ataxia types 1 and 2. Achievement of therapeutic benefit with this combination approach requires that effective concentrations of both agents reach the systemic circulation, and ultimately reach the intended pharmacologic target. This in turn requires understanding of the clinical pharmacokinetic properties of both drugs when administered individually, as well as knowledge of the extent to which the agents might interact when given concurrently.

Study Objectives:

1. To evaluate the pharmacokinetic properties of baclofen and CHZ when administered as individual entities at separate times, using customary clinical doses.

2. To compare the pharmacokinetic properties, and assess the bioequivalence, of each drug administered separately compared to administration of the two drugs concurrently.

3. To assess adverse events attributed to the two drugs when administered separately or together.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Tufts University
• Treatments: Baclofen; Chlorzoxazone

Criteria

Inclusion Criteria:

• Healthy male or female

• Ages 18 to 50 years of age

• Ambulatory

• Non-smoker

• No current or past history of significant medical or psychiatric disease

• Not currently taking prescription medications or on a regular or recurrent basis

Exclusion Criteria:

• Non-ambulatory

• Smokers

• Current or past history of significant medical or psychiatric disease

• Currently taking prescription medications or taking on a regular or recurrent basis

• Available information about potential participant indicates that participation would not be safe or appropriate, per PI discretion