Epilepsy seizures
Conditions
Interventions
OPC-214870 (3 dose strengths) tablets or matching placebo tablets once daily
for 8 consecutive days.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Male or female subjects between 18 and 55 years of age, inclusive. 2) Body mass index (BMI) between 19.0 to 32.0 kg/m2 (inclusive). 3) In good health as determined by: a) Medical history b) Physical examination c) Neurological examination d) Vital signs e) Electrocardiogram (ECG) f) Spirometry g) Serum/urine biochemistry, hematology, and serology tests. 4) Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigator medicinal product 2) Sexually active men or women of childbearing potential (WOCBP), or their partners, who do not agree to practice 2 different approved methods of birth control (ie, vasectomy, tubal ligation, nonhormonal intrauterine device, condom with spermicide, sponge with spermicide, or occlusive cap [vaginal diaphragm or cervical/vault cap] with spermicide) or remain fully abstinent (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] or withdrawal are not acceptable methods of contraception) during the trial and for 90 days after the last dose of IMP. If employing birth control, male subjects must use condom with spermicide plus one of the approved methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic: The assessments include questionnaires and tests on vigilance, attention and eye-hand coordination, among various other tests. Pharmacokinetic: OPC-214870 plasma concentrations, AUC0-24h, and Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| • Reported AEs, vital sign measurements, ECGs, clinical laboratory tests, physical examinations, neurological examinations, the C-SSRS, and pulmonary function tests. | — |
Countries
Netherlands
Outcome results
None listed