Clinical trial NCT01796899: Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers
Official title: A Randomized, Single-center, Open-label, 5-way Crossover, Single-dose Bioavailability/Bioequivalence Comparison of Brivaracetam Oral Tablets (10 mg, 50 mg,75 mg, and 100 mg) and Brivaracetam Intravenous Bolus Injection (100 mg) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Brivaracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
timeFrame: 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
measure: 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])
timeFrame: 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
measure: Area under the plasma concentration-time curve from zero to infinity dose-normalized to the 50 mg reference treatment (AUC)
timeFrame: 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 outcomes:
measure: Plasma half-life of Brivaracetam
timeFrame: 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
measure: Time to reach the maximum plasma concentration of Brivaracetam (tmax)
timeFrame: 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
measure: Apparent oral clearance of Brivaracetam (CL/F)
timeFrame: 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
measure: Apparent volume of Brivaracetam distribution at the terminal elimination phase
timeFrame: 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
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: 1
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: