A PHASE 1, OPEN-LABEL, PHARMACOKINETIC TRIAL TO INVESTIGATE POSSIBLE DRUG-DRUG INTERACTIONS BETWEEN CLOBAZAM, STIRIPENTOL OR VALPROATE AND CANNABIDIOL (GWP42003-P) IN HEALTHY SUBJECTS

Completed

• Conditions: epilepsy; 10039911

• Registration Number: NL-OMON43875
• Lead Sponsor: GW Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

- healthy male/ female subjects
- 18-55 yrs, inclusive
- BMI: 18.0-32.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / 1.0 liters of blood (for women) 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>The effect of multiple dose administration of GWP42003-P on steady state plasma<br /><br>concentrations of clobazam, stiripentol or valproate will be assessed. In<br /><br>addition, the effec tof multiple dose administration of clobazam, stiripentol<br /><br>or valproate on steady state plasma concentrations of GWP42003-P will be<br /><br>assessed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety and tolerability of GWP42003-P with clobazam, stiripentol or<br /><br>valproate will be assessed with respect to:<br /><br>- adverse events<br /><br>- vital signs<br /><br>- ECG<br /><br>- Clinical laboratory parameters<br /><br>- physical examination<br /><br>- C-SSRS</p><br>