A Phase I study to evaluate the safety, tolerability, and pharmacokinetics of NTX-083 in healthy adult males.

JRCT ID: jRCT2031240660

Registered date:04/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 01/02/2025
• Target sample size: 40
• Study type: Interventional
• Intervention(s): A capsule formulation containing NTX-083 or placebo is given as a single, oral dose with 200 mL (up to an additional 100 mL allowed) of water.

Outcome(s)

• Primary Outcome: To evaluate the safety, tolerability, and pharmacokinetics of NTX-083 in healthy adult males.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 50age old
• Gender: Male

Include criteria

1) A healthy Japanese male.
2) An individual who is age of 18 years or more and less than 50 years at the time of consent.
3) An individual who, in Eligibility Tests 1 and 2, has a systolic blood pressure >=90 mmHg and<=139 mmHg, a diastolic blood pressure >=50 mmHg and <=89 mmHg, and a heart rate >=55 and <=100 beats per minute.
4) An individual who has been provided sufficient explanation about participating in this clinical study, upon full understanding, and who has given his written consent of his own free will.
5) An individual who is able to be hospitalized and visit as outpatient the study site according to the study schedule.
6) An individual who has agreed to medically appropriate contraception (including prohibition of sperm donation) from the start of dosing of the study drug to 30 days after the final dosing. Medically appropriate contraception refers to not having sexual intercourse, undergone surgical sterilization such as vasectomy, use of intrauterine contraceptive devices, oral contraceptives, or condoms.

Exclude criteria

1) An individual who, in the laboratory tests, vital signs, or 12-lead ECG results of the Eligibility Test 1 (Day -28 to Day -2) or Eligibility Test 2 (Day -1), is judged by the principal investigator or subinvestigator to have clinically abnormalities.
2) An individual who, in the 12-lead ECG results of the Eligibility Test 1 (Day -28 to Day -2) or Eligibility Test 2 (Day -1), is having QTcF value of >450 msec.
3) An individual who, in the Eligibility Test 1 (Day -28 to Day -2) or Eligibility Test 2 (Day -1), is having body weight of <50.0 kg.
4) An individual who, in the Eligibility Test 1 (Day -28 to Day -2) or Eligibility Test 2 (Day -1), is having BMI of <18.5 or >30.
5) An individual who, in the Eligibility Test 1 (Day -28 to Day -2), is having positive result of HBs antigen test, HBc antibody, HCV antibody test, HIV antigen/antibody test or qualitative syphilis test.
6) An individual who, in the medical interview of the investigator or subinvestigator and urine drug abuse testing of the Eligibility Test 1
(Day -28 to Day -2), have been determined to have a history of alcohol dependence or drug dependence.
7) An individual who, in kidney, liver, heart, central nervous/psychiatry system, etc., has a disease history considered to be unsuitable for this study (for example, renal failure, kidney dialysis, liver failure, myocardial infarction, angina, cardiomyopathy, heart failure, cerebral infarction, etc.).
8) An individual who has a history of disease or surgery (for example, gastrectomy, gastric binding surgery, gastric bypass surgery, etc.) that may affect the absorption of the investigational drug.
9) An individual who has a history or complication of drug allergy.
10) An individual who is not able to abstain from smoking during hospitalization.
11) An individual who has used any medicine within 7 days up to Day 1. However, quasi drugs are allowed to be used.
12) An individual who has taken grapefruit or St. John's Wort (Western Hypericum), or foods or beverages containing them within 7 days up to Day 1.
13) An individual who has taken sulfonylurea (SU) within 12 weeks up to Day 1.
14) An individual who has hospitalized or undergone invasive procedures accompanied by bleeding such as surgery, within 12 weeks up to Day 1.
15) An individual who has participated in clinical research including other clinical trial, or taken other investigational drug, within 16 weeks up to Day 1.
16) An individual who has donated component blood within 2 weeks up to Day 1, or who had at least 200 mL of blood drawn within 4 weeks, or who had at least 400 mL of blood drawn within 12 weeks.
17) An individual who has engaged in intense exercise (such as marathons, muscle training) within 2 weeks up to Day 1.
18) An individual who, by Columbia Suicide Severity Rating Scale (C-SSRS) or by the clinical judgment of the investigator, has a risk of suicide (a score of 4 or 5 for suicidal ideation or behavior), who has attempted suicide in the past 6 months, or who has a history of intentional self-mutilation in the past 6 months.
19) Other, in the opinion of the investigator or subinvestigator, an individual who is judged to be inappropriate as a subject.

Related Information

• Primary Sponsor: Maruyama Tatsuya