Single- and Multiple-dose Intravenous Administration Trial of PCN-101 in Healthy Adult Male Subjects

JRCT ID: jRCT2071210139

Registered date:26/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Treatment-resistant Depression
• Date of first enrollment: 18/04/2022
• Target sample size: 42
• Study type: Interventional

Intervention(s)

(Part1)
A single dose of PCN-101 or placebo will be administered by intravenous infusion over 40 minutes.
(Part2)
Multiple doses of PCN-101 or placebo will be administered by intravenous infusion over 40 minutes each time, twice weekly for 2 weeks.

Outcome(s)

Primary Outcome

(Safety endpoints)
-Clinical laboratory tests (hematology, blood biochemistry, and urinalysis)
-Physical examination
-Vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)
-Oxygen saturation
-12-lead ECG
-C-SSRS
-MOAA/S
-CADSS
-BPRS+
-Dependence assessment
-Adverse events
(Pharmacokinetic endpoints)
Plasma drug concentrations and plasma pharmacokinetic parameters of PCN-101 and its metabolites (norketamine, 6-hydroxynorketamine, and dehydronorketamine)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Healthy Japanese male subjects aged 20 years or older and younger than 40 years
at the time of informed consent
2) Subjects with a body mass index (BMI = body weight [kg] / height [m]2) of
18.5 kg/m2 or higher and lower than 25.0 kg/m2 at screening
3) Subjects with the ability to provide written informed consent prior to initiation of
any trial-related procedures, and the ability, in the opinion of the principal
investigator or subinvestigator, to comply with all the requirements of the trial

Exclude criteria

1) Subjects with clinically significant abnormalities (eg, significant deviation from the normal range) of screening examinations, admission examinations, or in the medical history that could potentially pose a risk to the subject or affect such endpoints as absorption, distribution, metabolism, or excretion of the drug as judged by the principal investigator, subinvestigator, or sponsor. These include, but are not limited to, a history or current symptoms of cardiac, hepatic, renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.
2) Subjects with a systolic blood pressure of more than 140 mmHg or less than 100 mmHg or a diastolic blood pressure of more than 90 mmHg or less than 50 mmHg in a supine, sitting, or standing position while at rest for 3 minutes or longer (at screening or admission), or with a decrease in blood pressure due to standing (difference between"supine systolic blood pressure"and "standing systolic blood pressure") of more than 20 mmHg (at screening). However, if the principal investigator or subinvestigator determines that there are no clinical problems, even if the parameter is outside the range, judgement on exclusion should be made after remeasurement.
3) Subjects with a pulse rate outside the range of 50 to 90 bpm in a supine, sitting, or standing position while at rest for 3 minutes or longer (at screening or admission) However, if the principal investigator or subinvestigator determines that there are no clinical problems, even if the parameter is outside the range, judgement on exclusion should be made after remeasurement.
4) Subjects with clinically significant ECG findings on 12-lead ECG; eg, atrioventricular block, QRS interval of at least 120 msec, QTcF interval of at least 450 msec, etc. (at screening or admission)
5) Subjects who fall under the following criteria for hepatitis
-Subjects with a history or current symptoms of hepatitis B, or current symptoms of hepatitis C. Subjects who test positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening
-Subjects with a history or current symptoms of alcoholic hepatitis or nonalcoholic steatohepatitis
6) Subjects who have acquired immunodeficiency syndrome (AIDS) or a history of human immunodeficiency virus (HIV) infection. Subjects who test positive for HIV or syphilis (at screening). Subjects with a positive polymerase chain reaction (PCR) test for SARS coronavirus 2 (SARS-CoV-2) (at admission)
7) Subjects with mental disorders or a history of the following mental disorders based on the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
-Schizophrenia spectrum disorders and other psychotic disorders, bipolar and related disorders, depressive disorders, substance-related disorders and addictive disorders, and personality disorders

Related Information

• Primary Sponsor: Matsumaru Takehisa