Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Brivaracetam 10 mg oral tablet; Other: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL); Other: Brivaracetam 100 mg oral tablet; Other: Brivaracetam 75 mg oral tablet; Other: Brivaracetam 50 mg oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01796899

2012-001358-25 (EudraCT Number)

EP0007

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

25 participants in 5 patient groups

Brivaracetam 10 mg oral tablet

Other group

Description:

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

Treatment:

Other: Brivaracetam 10 mg oral tablet

Brivaracetam 50 mg oral tablet

Other group

Description:

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

Treatment:

Other: Brivaracetam 50 mg oral tablet

Brivaracetam 75 mg oral tablet

Other group

Description:

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

Treatment:

Other: Brivaracetam 75 mg oral tablet

Brivaracetam 100 mg oral tablet

Other group

Description:

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

Treatment:

Other: Brivaracetam 100 mg oral tablet

10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)

Other group

Description:

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

Treatment:

Other: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)