A Phase 1 Clinical Trial of EB-1020 in Healthy Subjects (Single and Multiple Ascending Doses)

JRCT ID: jRCT2071220029

Registered date:25/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Attention deficit hyperactivity disorder (ADHD)
• Date of first enrollment: 15/07/2022
• Target sample size: 55
• Study type: Interventional

Intervention(s)

[Part A]
Subjects will receive single oral administration of EB-1020 once-daily extended-release(QD XR) capsule(82.2,164.4,or 328.8mg) or placebo capsule.
[Part B]
Subjects will receive 5-day repeated oral administration of EB-1020 QD XR capsule(164.4 or 328.8mg/day) or placebo capsule.

Outcome(s)

Primary Outcome

Safety endpoints
-Adverse events (AEs)
-Clinical laboratory tests (hematology, blood chemistry, urinalysis)
-Physical examination
-Neurological examination
-Vital signs (blood pressure, pulse rate, body temperature, respiratory rate)
-Body weight
-12-Lead electrocardiogram (ECG)
-Columbia-Suicide Severity Rating Scale (C-SSRS)
Pharmacokinetic endpoints
-Plasma concentrations of EB-1020 and EB-10601
-Pharmacokinetic parameters of EB-1020 and EB-10601
-Cumulative parameters of EB-1020 and EB-10601
-AUC ratio for EB-10601 to EB-1020
-Dose proportionality of Cmax and AUC of EB-1020 and EB-10601

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Japanese males age 18 years or older and younger than 40 years at the time of informed consent
2) Body mass index (BMI = body weight(kg)/(height{m})2) of>=19.0kg/m2 and=<25.0kg/m2 at screening
3) Body weight of>=50kg at screening
4) Subjects who are capable of providing their own signed informed consent prior to the start of any trial-related procedure and who are judged by the investigator or subinvestigator to be capable of meeting all of the requirements of the trial

Exclude criteria

1) Subjects 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 the evaluation endpoints, including drug absorption, distribution, metabolism, or excretion
This may include, but is not limited to, a medical history or complication of cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, or immunologic disease.
2) Subjects with systolic blood pressure of >140mmHg or <100mmHg or diastolic blood pressure of >90mmHg or <50mmHg after at least 3 minutes rest in the supine, sitting, or standing position (at either screening or admission), or with orthostatic blood pressure decrease (systolic blood pressure in supine position minus systolic blood pressure in standing position) of >=20mmHg(at screening)
3) Subjects whose pulse rate in the supine position after resting for at least 3 minutes is not within the range of 50 to 90bpm(at either screening or admission)
4) Subjects who have a medical history or current symptoms of hepatitis or acquired immunodeficiency syndrome
5) Subjects with a positive result in immunological tests (hepatitis B surface antigen[HBsAg], hepatitis C virus(HCV)antibody, human immunodeficiency virus[HIV] antigen and antibody, syphilis) or polymerase chain reaction (PCR) test (SARS-CoV-2) at screening
6) Subjects with a history of drug allergy
7) Subjects with a positive result in alcohol breath test or urine drug test at screening or admission (positive result for alcohol breath test: concentration of >0.00 mg/L)

Related Information

• Primary Sponsor: Sanada Nobuhito