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

April 12, 2013 updated by: UCB Pharma SA

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
Other: 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
Other: 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
Other: 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
Other: 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
Other: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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

Outcome Measure
Time Frame
Plasma half-life of Brivaracetam
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
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)
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
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)
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (ESTIMATE)

February 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP0007
  • 2012-001358-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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