- To assess the CNS functional effects of OPC-214870 following dosing using Neurocart test battery
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
• Reported AEs, vital sign measurements, ECGs, clinical laboratory tests,
physical examinations, neurological examinations, the C-SSRS, and pulmonary
function tests.
Background summary
The pharmacology of OPC-214870 has been characterized using both in vitro and
in vivo models. OPC-214870 may represent a potential treatment option for
seizure disorders. Results suggest that OPC-214870 may represent a potential
treatment option for seizure disorders that warrants further investigation.
This clinical trial seeks to better understand the pharmacodynamic effects
OPC-214870 has not been fully elucidated. In this regard, the translatability
of the nonclinical findings will be further investigated using CHDR Neurocart
battery and also whether the PD endpoints obtained are similar or different
from known antiseizure medications.
.
Study objective
- To assess the CNS functional effects of OPC-214870 following dosing using
Neurocart test battery
Study design
This is a phase 1, randomized, double-blind, placebo-controlled trial to
determine the pharmacodynamics (PD) and pharmacokinetics (PK) of OPC-214870
following repeated dosing in healthy adult subjects.
Intervention
OPC-214870 (3 dose strengths) tablets or matching placebo tablets once daily
for 8 consecutive days.
Study burden and risks
Overall, OPC-214870 has been safe and well-tolerated in phase 1 clinical
trials. No serious adverse events (SAEs) were reported for single doses from 10
mg to 1000 mg. OPC-214870 administered as multiple ascending doses was well
tolerated. The AEs in subjects receiving single or multiple doses of OPC-214870
were mainly associated with the central nervous system (CNS) and were mild or
moderate in severity. The NeuroCart is considered minimally burdensome but
still sensitive to the PD effects of a vast array of different CNS active
drugs. Overall the burden and risks associated with this study are considered
acceptable and justifiable. The primary goal of this study is to investigate
the pharmacodynamics of OPC-214870 therefore the trial population will consist
of healthy males and females, 18 to 55 years of age, inclusive.
Research Blvd 2440
Rockville MD 20850
US
Research Blvd 2440
Rockville MD 20850
US
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001826-31-NL |
| CCMO | NL81722.056.22 |