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

Phase 1

Completed

• Conditions: Healthy Study Participants
• Interventions: Drug: brivaracetam (BRV) tablet; Drug: brivaracetam (BRV) dry syrup

• Registration Number: NCT06312566
• Lead Sponsor: UCB Biopharma SRL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-03-25
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A-B	brivaracetam (BRV) tablet	Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
Treatment A-B	brivaracetam (BRV) dry syrup	Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
Treatment B-A	brivaracetam (BRV) tablet	Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.
Treatment B-A	brivaracetam (BRV) dry syrup	Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration at steady state [Cmax(ss)] after multiple doses of brivaracetam	Day 3	Cmax,ss=maximum plasma concentration at steady state
Area under the curve during a dosing interval at steady state [AUC(tau)] after multiple doses of brivaracetam	Day 3	AUCtau=Area under the curve during a dosing interval at steady state

Secondary Outcome Measures

Name	Time	Method
Percentage of study participants with treatment-emergent adverse events (TEAEs)	From Baseline to end of Safety Follow-Up, up to 25 days	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of Investigational Medicinal Product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs)	From Baseline to end of Safety Follow-Up, up to 25 days	A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death; * Is life-threatening; * Requires in patient hospitalization or prolongation of existing hospitalization; * Results in persistent disability/incapacity; * Is a congenital anomaly/birth defect; * 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.
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation	From Baseline to end of Safety Follow-Up, up to 25 days	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of Investigational Medicinal Product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.

Trial Locations

Locations (1)

EP0231 1; 🇯🇵 Sumida-ku, Japan