A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Assessthe Tolerability, Safety, and Pharmacokinetics of Single Ascending Oral Tablet Doses ofOPC-224333 in Healthy Male and Female Subjects (Arm 1)

Otsuka Pharmaceutical Development & Commercialization, Inc0 sites72 target enrollmentMarch 23, 2022

ConditionsEpilepsy Neurological - Epilepsy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Epilepsy
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc
Enrollment: 72
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 23, 2022

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc

Eligibility Criteria

Inclusion Criteria

•Participants are required to meet the following inclusion criteria when assessed:
•1\) Male and nonchildbearing potential (NCBP) female participants 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) Electrocardiogram (ECG)
•e) 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

•Participants will be excluded if they meet any of the following exclusion criteria when
•1\) Clinically significant abnormality in past medical history or at the screening physical examination (including but not limited to clinical laboratory tests), that in the investigator’s or sponsor’s opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of the IMP. This includes, but is not limited to, history of or concurrent cardiac, hepatic (liver function tests \> 1\.5 × upper limit of normal \[ULN] at screening/baseline), renal (estimated glomerular filtration rate per chronic kidney disease epidemiology formula \<60 mL/min), neurologic, endocrine,
•gastrointestinal, respiratory, hematologic, and immunologic disease.
•2\) History of drug and/or alcohol abuse within 2 years prior to screening.
•3\) History of or current hepatitis or acquired immunodeficiency syndrome or carriers
•of hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti\-HCV), and/or human immunodeficiency virus (HIV) antibodies. Exceptions are permitted for subjects with a prior history of infection with hepatitis A who have fully recovered and are experiencing no liver sequelae, or with hepatitis C who have been adequately treated to be considered cured with no liver sequelae.
•4\) History of any medically significant allergy.
•5\) A positive urine or breath alcohol test and/or a positive urine drug screen for substance of abuse at screening or upon check\-in to the trial site.
•6\) Subject having taken an investigational drug within 30 days preceding screening or a biological investigational drug within 30 days or 5 half\-lives (whichever is longer) preceding screening,
•7\) Any history of significant bleeding or hemorrhagic tendencies.