Alzheimer's Disease Alzheimer Disease
Conditions
Interventions
A capsule formulation containing NTX-083 or placebo is administered orally with sigle daily dosing for 7 days
Sponsors
Hanada Ryuzo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] An individual capable of fully understanding the study details and possessing the capacity to provide informed consent. [2] A Japanese healthy male with both parents and grandparents being Japanese (Part 1). [3] A Caucasian (including Hispanic/Latino) healthy male with both parents and grandparents being Caucasian (including Hispanic/Latino) (Part 2). [4] An individual who is of age 18 years or more and less than 50 years at the time of consent. [5] An individual who is able to be hospitalized and visit as outpatient the study site according to the Schedule of Activities.
Exclusion criteria
Exclusion 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 clinical 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 =30.0. [5] An individual who, in the Eligibility Test 1 (Day -28 to Day -2), is having positive result of HBs antigen test, HCV antibody test, HIV antigen/antibody test, or qualitative syphilis test (TP antibody method, RPR method). [6] An individual who, in the medical interview of the principal investigator or subinvestigator, has been determined to have a history of alcohol dependence or drug dependence. [7] An individual with a complication or history of hematologic disease, hemorrhagic disease, renal disease, metabolic disease, endocrine disease, pulmonary disease, gastrointestinal disease, urinary disease, cardiovascular disease, hepatic disease, psychiatric disease, neurological disease, or allergic disease (excluding seasonal allergies at the time of administration). [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 the study. [11] An individual who has used any medication within 4 weeks up to Day 1. [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 was hospitalized or underwent surgical treatment within 12 weeks up to Day 1. [15] An individual who participated in another study or an NTX-083 study within 16 weeks up to Day 1, or whose observation period for another study or NTX-083 study has not concluded by the date of consent. [16] An individual who has donated component blood within 2 weeks, 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 up to Day 1. [17] An individual unwilling to use medically appropriate contraception if their female partner is of childbearing potential, from hospitalization until 30 days after the final dose. A woman of childbearing potential is defined as a woman who has not undergone surgical sterilization (e.g., hysterectomy, tubal ligation) or is not postmenopausal (at least 2 years since last menstruation). Medically appropriate contraception includes abstinence, surgical sterilization (e.g., vasectomy), intrauterine devices, oral contraceptives, or condoms. [18] An individual with a history or findings of suicidal ideation or behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS) evaluation during Eligibility Test 2 (Day -1). [19] Other, in the opinion of the principal investigator or subinvestigator, an individual who is judged to be inappropriate as a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability, and pharmacokinetics of NTX-083 multiple dosing in healthy adult males. | — |
Contacts
Public ContactAyato Satomi
Neusignal Therapeutics, Inc.
Outcome results
None listed