A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants

UCB Biopharma SRL64 enrolled

Overview

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Study Participants

Interventions

brivaracetam (BRV) tabletDRUG

Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.

brivaracetam (BRV) dry syrupDRUG

Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF) * Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan) * Participant is male Exclusion Criteria: * Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations * Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device) * Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1 * Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP * Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP

Locations (1)

EP0231 1

Sumida-ku, Japan

Outcomes

Primary Outcomes

Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam

Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.

Time frame: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose

Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam

AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.

Secondary Outcomes

Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)

An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.

Time frame: From Baseline to end of Safety Follow-up (up to 25 days)

Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)

A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Is a congenital anomaly or birth defect, Results in persistent disability/incapacity Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.

Data from ClinicalTrials.gov

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