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.

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. - SAD/MAD/DDI study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36253

Enrollment

129

Registered

2010-12-06

Start date

2010-01-05

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Migraine

Interventions

Part 1 (SAD) Cohort 1: a single oral dose of 240 mg tonabersat or placebo on Day 1 fasted Cohort 2, period 1: a single oral dose of 320 mg tonabersat or placebo on Day 1 fasted Cohort 2, period 2: a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)