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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- UCB Pharma SA
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Brivaracetam 10 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 10 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
- Strength: 10 mg
- Form: Oral tablet
- Frequency: Once daily
- Duration: 1 day
Intervention: Brivaracetam 10 mg oral tablet (Other)
Brivaracetam 50 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 50 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
- Strength: 50 mg
- Form: Oral tablet
- Frequency: Once daily
- Duration: 1 day
Intervention: Brivaracetam 50 mg oral tablet (Other)
Brivaracetam 75 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 75 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
- Strength: 75 mg
- Form: Oral tablet
- Frequency: Once daily
- Duration: 1 day
Intervention: Brivaracetam 75 mg oral tablet (Other)
Brivaracetam 100 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 100 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
- Strength: 100 mg
- Form: Oral tablet
- Frequency: Once daily
- Duration: 1 day
Intervention: Brivaracetam 100 mg oral tablet (Other)
10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of 10 mL of BRV intravenous bolus injection (10 mg/mL) will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
- Strength: 100 mg (10 mg/mL)
- Form: Intravenous bolus injection
- Frequency: Once daily
- Duration: 1 day
Intervention: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) (Other)
Outcomes
Primary Outcomes
Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
Time Frame: 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])
Time Frame: 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)
Time Frame: 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
- 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)
- 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 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)
- 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)