A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF BRIVARACETAM INTRAVENOUS FORMULATION GIVEN AS A 2-MINUTE IV BOLUS INJECTION, A 15-MINUTE IV INFUSION, AND AN ORALLY-DOSED TABLET IN HEALTHY MALE JAPANESE SUBJECTS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223863

Enrollment

Registered

2018-04-10

Start date

2018-04-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

investigational material(s) Generic name etc : ucb 34714 INN of investigational material : brivaracetam Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Subject is of normal body weight of 50 to 90kg(inclusive) and body mass index between 18.5 and 26kg/m2. 2)Subject is willing to abstain from alcohol-, tabacco, and caffeine-containing products for 48 hours prior to admissions to the study site and during the entire in-site stay. 3)Subjects has blood pressure and pulse rate measurement within normal range, and axillary body temperature between 35.0-37.5 degree.Clinically nonsignificant will be allowed at the discretion of the investigator. 4)Subject's ECG is considered normal or abnormal but not clinically significant, in the opinion of the investigator. 5)Result of clinical laboratory tests whithin the reference of the laboratory. Results outside the reference range of the laboratory but considered as not clinically significant by the investigator.

Exclusion criteria

Exclusion criteria: 1)Subjects has a current serious psychiatric disorder requiring or that has required hospitalization or medication within the previous 5 years. 2)Subjects has a history of chronic alcohol or drug abuse within previous 6 months. 3)Subjects consumes >40g alcohol/day 4)Subjects has any concomitant choronic or acute illness. 5)Subjects is known to have serum hepatitis or is a carrier of HBsAg, HCV, HIV or syphilis. 6)Subjects has donated blood or blood components or experienced blood loss >400mL within 90days, >200mL within 30 days, or any blood or blood components within 14days of the first IMP administration.

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics PK, safety, AUC, Cmax, tmax, t1/2 AE etc.	—

Secondary

Measure	Time frame
safety efficacy Efficacy, Safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026