NCT01796899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

February 19, 2013

Last Update Submit

April 12, 2013

Conditions

Healthy Volunteers

Keywords

Healthy VolunteersBrivaracetam

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (5)

Brivaracetam 10 mg oral tablet

OTHER

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

Other: Brivaracetam 10 mg oral tablet

Brivaracetam 50 mg oral tablet

OTHER

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

Other: Brivaracetam 50 mg oral tablet

Brivaracetam 75 mg oral tablet

OTHER

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

Other: Brivaracetam 75 mg oral tablet

Brivaracetam 100 mg oral tablet

OTHER

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

Other: Brivaracetam 100 mg oral tablet

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

OTHER

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

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

Interventions

Brivaracetam 10 mg oral tabletOTHER
Brivaracetam 10 mg oral tablet
Brivaracetam 50 mg oral tabletOTHER
Brivaracetam 50 mg oral tablet
Brivaracetam 75 mg oral tabletOTHER
Brivaracetam 75 mg oral tablet
Brivaracetam 100 mg oral tabletOTHER
Brivaracetam 100 mg oral tablet
10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)OTHER
10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1

Zuidlaren, Netherlands

Location

MeSH Terms

Interventions

brivaracetamTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 22, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

NL(1)