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

Healthy Study Participants Clinical Trial

Official title:

A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312566
• Other study ID #: EP0231
• Status: Recruiting
• Phase: Phase 1
• Start date: March 25, 2024
• Est. completion date: October 25, 2024

Study information

• Verified date: April 2024
• Source: UCB Pharma
• Contact: UCB Cares
• Phone: 1-844-599-2273 (USA)
• Email: ucbcares[@]ucb.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 25, 2024
• Est. primary completion date: October 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Study Participants

Intervention

Drug:
• brivaracetam (BRV) tablet
Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.
• brivaracetam (BRV) dry syrup
Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Locations

Country	Name	City	State
Japan	Ep0231 001	Sumida- Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration at steady state [Cmax(ss)] after multiple doses of brivaracetam	Cmax,ss=maximum plasma concentration at steady state	Day 3
Primary	Area under the curve during a dosing interval at steady state [AUC(tau)] after multiple doses of brivaracetam	AUCtau=Area under the curve during a dosing interval at steady state	Day 3
Secondary	Percentage of study participants with treatment-emergent adverse events (TEAEs)	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.	From Baseline to end of Safety Follow-Up, up to 25 days
Secondary	Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs)	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.	From Baseline to end of Safety Follow-Up, up to 25 days
Secondary	Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation	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.	From Baseline to end of Safety Follow-Up, up to 25 days