Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Other: Brivaracetam 100 mg oral tabletOther: Brivaracetam 10 mg oral tabletOther: Brivaracetam 50 mg oral tabletOther: Brivaracetam 75 mg oral tabletOther: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
- Registration Number
- NCT01796899
- Lead Sponsor
- UCB Pharma SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Brivaracetam 100 mg oral tablet 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 Brivaracetam 10 mg oral tablet 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 Brivaracetam 50 mg oral tablet 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 Brivaracetam 75 mg oral tablet 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 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
1
🇳🇱Zuidlaren, Netherlands