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A single-center, parallel-group, randomized, placebo-controlled, double-blind, phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of single oral administration of OPC-184337 in healthy adult males

A single oral administration trial of OPC-184337 in healthy adult males

Tsunoda Takeshi

Otsuka Pharmaceutical Co., Ltd.

2-16-4, Konan, Minato-ku, Tokyo, Japan

OPC_CL_OPC184337_SAD@otsuka.jp

Drug Information Center

Otsuka Pharmaceutical Co., LTD.

2-16-4, Konan, Minato-ku, Tokyo, Japan

+81-3-6361-7314

opc_ctr@otsuka.jp

Pending

Nov. 25, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

1) Japanese males at least 18 years of age and below the age of 40 at the time of informed consent
2) Body mass index (BMI) at least 18.5 kg/m2 and less than 25.0 kg/m2 at screening
3) Body weight of at least 50 kg at screening
4) Individuals who are able to provide personally signed informed consent prior to initiation of any trial-related procedures and who are judged by the investigator or subinvestigator to be capable of meeting all of the requirements of the trial

1)Individuals who, on the basis of their medical history or the physical examination at either screening or admission, are judged by the investigator or subinvestigator to be placed at risk or to have a clinically significant abnormality that might possibly affect drug absorption, distribution, metabolism, and excretion or the evaluation endpoints.
This may include, but is not limited to, a medical history or complication of cardiovascular, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, or immunologic disease.
2)Individuals with systolic blood pressure higher than 140 mmHg or lower than 100 mmHg or diastolic blood pressure higher than 90 mmHg or lower than 50 mmHg in the supine or standing position after resting for at least 3 minutes (at screening or admission), or with a decrease from the supine position due to standing of more than 20 mmHg for systolic blood pressure or more than 10 mmHg for diastolic blood pressure (at screening)
If a measured value is outside the specified range but is not considered clinically meaningful in the opinion of the investigator or subinvestigator, 3 measurements should be taken at intervals of at least 10 minutes. Unless 2 of the 3 additional measurements fall under the range specified in the exclusion criteria, the individual is not considered to meet the exclusion criteria. If the first and second additional measurements do not fall under the range specified in the exclusion criteria, the third measurement is not necessary.
3)Individuals with a pulse rate at rest in the supine position outside the range of 50 to 90 bpm after resting for at least 3 minutes (at screening or admission)
If a measured value is outside the specified range but is not considered clinically meaningful in the opinion of the investigator or subinvestigator, 3 measurements should be taken at intervals of at least 10 minutes. Unless 2 of these 3 measurements fall under the range specified in the exclusion criteria, the individual is not considered to meet the exclusion criteria. If the result of re-measurement is within the range of 40 to 49 bpm but the investigator or subinvestigator considers that the individual is healthy and that there is no clinical problem, the individual is not considered to meet the exclusion criteria.
4)Individuals with a history of convulsive disorder (eg, epilepsy), head trauma, etc, or who have a first-degree relative (parent) with a history of epilepsy (excluding symptomatic epilepsy)
5)Individuals with abnormal EEG findings in the examination using activation methods (photostimulation, hyperventilation) from screening through the run-in period (Day -28 to Day -1;only in cohorts in which EEG is performed) (see Section 5.7.1)
6)Individuals with a diagnosis of angle-closure glaucoma
7)Individuals who have a medical history or current symptoms of hepatitis or acquired immunodeficiency syndrome or who have a positive result in immunological tests (hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] antigen and antibody, and syphilis) at screening
8)Individuals with clinically significant 12-lead ECG findings, such as atrioventricular block, PR interval of at least 200 msec, QRS interval of at least 120 msec, QTcF interval of at least 450 msec, etc (at screening)
9)Individuals with a history of long QT syndrome (including a family history), any type of syncopal attack, or unexplained loss of consciousness
10)Individuals with prior or current serious mental disorders that could be a valid reason for exclusion from the trial in the opinion of the investigator or subinvestigator

Male

Attention-deficit hyperactivity disorder (ADHD)

Single oral doses of OPC-184337 tablets or placebo tablets will be administered. Administration of OPC-184337 will start at a dose of 0.25 mg and the dose will be increased incrementally to 0.5, 1, 2, 4, 6, 9, 13.5, and 20 mg, proceeding to each subsequent dose after the safety, tolerability, and pharmacokinetics of OPC-184337 have been confirmed. The trial will not proceed to each subsequent cohort if tolerability is not confirmed. Based on the results of the safety and pharmacokinetic confirmation for each cohort, the trial may proceed to the next cohort after making changes or additions to the planned doses.

Safety Endpoints
-AEs
-Clinical laboratory tests (hematology, blood chemistry, urinalysis)
-Physical examination findings
-Neurological examination
-Vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)
-Body weight
-12-Lead ECG
-C-SSRS
-EEG

Pharmacokinetic Endpoints
-Plasma concentration of OPC-184337
-Pharmacokinetic parameters of OPC-184337

+81-92-283-7701

Yes

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data. Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

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