Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Brivaracetam
Brief summary
To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
Interventions
OTHERBrivaracetam 10 mg oral tablet
OTHERBrivaracetam 50 mg oral tablet
OTHERBrivaracetam 75 mg oral tablet
OTHERBrivaracetam 100 mg oral tablet
OTHER10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
Sponsors
UCB Pharma SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is a healthy male or female volunteer aged 18-55 years inclusive * Subject has a Body Mass Index (BMI) of 18.0 - 30.0 kg/m\^2 and a weight of at least 50 kg (males) or 45 kg (females) * Subject has normal vital signs values, Electrocardiograms (ECGs) and clinical laboratory values * Female subjects should have a negative pregnancy test or be of non-childbearing potential
Exclusion criteria
* Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months * Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters) * Subject has an intolerance or allergy against the compound or related drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax) | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
| Area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification dose-normalized to the 50 mg reference treatment (AUC[0-t]) | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
| Area under the plasma concentration-time curve from zero to infinity dose-normalized to the 50 mg reference treatment (AUC) | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach the maximum plasma concentration of Brivaracetam (tmax) | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
| Apparent volume of Brivaracetam distribution at the terminal elimination phase | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
| Plasma half-life of Brivaracetam | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
| Apparent oral clearance of Brivaracetam (CL/F) | Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose |
Countries
Netherlands
Outcome results
None listed