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

Healthy Study Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315947
• Other study ID #: EP0110
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2022
• Est. completion date: May 13, 2022

Study information

• Verified date: March 2023
• Source: UCB Pharma
• Contact: n/a
• 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 as dry syrup after a single oral dose in healthy Japanese male study participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion criteria:

• Study participant must be between 20 to 50 years of age (inclusive) at the time of signing the Informed Consent Form (ICF)
• Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• Study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a study participant has all 4 Japanese grandparents born in Japan)

Exclusion criteria:

• Study participant has used other drugs, including over-the-counter medications, herbal/traditional medicines, or dietary supplements (excluding medicines for external use),with the exception of paracetamol, within 14 days before first administration of IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of initiating IMP
• Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of Investigational Medicinal Product (IMP)
• Study participant has a positive result for hepatitis B surface antigen, hepatitis C virus antibody test, human immunodeficiency virus antibody test, or syphilis at Screening Visit
• Study 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
• Study participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
• Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola approximately 20 mg)

Related Conditions & MeSH terms

• Healthy Study Participants

Intervention

Drug:
• brivaracetam
Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.
• brivaracetam
Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.

Locations

Country	Name	City	State
Japan	EP0110 1	Sumida-ku

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 (Cmax) for a Single Dose of Brivaracetam	Cmax is the maximum plasma concentration of brivaracetam.	Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Primary	Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam	AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.	Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Secondary	Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	An AE was defined as 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.	From Baseline to end of Safety Follow-Up, up to 20 days
Secondary	Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)	A TEAE was 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, 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 20 days

External Links

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