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

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 - Cannabidiol drug-drug interaction trial with common anti-epileptic drugs

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43875

Enrollment

Registered

2015-10-01

Start date

2015-11-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy

Interventions

In this study 2 study compounds will be administered: CBD and clobazam, CBD and stiripentol or CBD and valproate.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The effect of multiple dose administration of GWP42003-P on steady state plasma concentrations of clobazam, stiripentol or valproate will be assessed. In addition, the effec tof multiple dose administration of clobazam, stiripentol or valproate on steady state plasma concentrations of GWP42003-P will be assessed.	—

Secondary

Measure	Time frame
The safety and tolerability of GWP42003-P with clobazam, stiripentol or valproate will be assessed with respect to: - adverse events - vital signs - ECG - Clinical laboratory parameters - physical examination - C-SSRS	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)