A double-blind, placebo controlled, randomized study to evaluate the safety, tolerability, pharmacokinetic profile and cytochrome P450 interaction potential of single and multiple doses of Tonabersat over the dose range of 240 mg to 480 mg in healthy adult subjects.

Completed

• Conditions: Migraine; 10019231

• Registration Number: NL-OMON36253
• Lead Sponsor: psher-Smith Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 129

Inclusion Criteria

18 - 65 years, BMI 18 - 30 kg/m2, no smoker or a moderate smoker i.e. * 5 cigarettes per day.

Exclusion Criteria

Suffering from: hepatitis A, B or C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics : cognitive and psychomotor performance<br /><br>Pharmacokinetics : plasma tonabersat, SB-277726, midazolam and<br /><br>1-hydroxymidazolam, metoprolol and<br /><br>*-<br /><br>hydroxymetoprolol, omeprazole plus 5'-hydroxy-omeprazole, caffeine<br /><br>paraxanthine<br /><br>and tolbutamide, 4-hydroxytolbutamide and carboxyltolbutamide concentrations,<br /><br>pharmacokinetic<br /><br>parameters<br /><br>Safety : adverse events, vital signs, ECG-parameters,<br /><br>laboratory parameters, physical examination,<br /><br>telemetry, suicidality, EEG parameters, audiometric parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>