A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Determine the Pharmacodynamics and Pharmacokinetics of OPC-214870 Following Repeated Oral Administration to Healthy Subjects

Recruiting

• Conditions: Epilepsy; seizures; 10039911

• Registration Number: NL-OMON51813
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic: The assessments include questionnaires and tests on vigilance,<br /><br>attention and eye-hand coordination, among various other tests.<br /><br>Pharmacokinetic: OPC-214870 plasma concentrations, AUC0-24h, and Cmax</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Reported AEs, vital sign measurements, ECGs, clinical laboratory tests,<br /><br>physical examinations, neurological examinations, the C-SSRS, and pulmonary<br /><br>function tests.</p><br>