Amyotrophic Lateral Sclerosis (ALS)
Conditions
Interventions
WN1316 solution 5mL is administered single dose orally. The dosage of WN1316 is 60 micrograms in step 1, 180 micrograms in step 2, 600 micrograms in step 3.
Placebo (Distilled water) 5 mL is admini
Sponsors
Clinical Research Hospital Tokyo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese adult males. (2) Between the ages of 20-35 at the time of informed consent. (3) Subjects determined by the investigator to be adequate for this study based on the screening tests. (4) Body mass index (BMI) is greater than or equal to 18.5 and less than 25.0. (5) Subjects who have negative result for hepatitis B virus surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV antigen and antibody), serological test for syphilis and treponema pallidum. (6) Non-smokers. (7) Subjects who are willing to follow study procedures during the study participation period. (8) Subjects signed informed consent form voluntary.
Exclusion criteria
Exclusion criteria: (1) Subject with serious concomitant or pre-existing conditions (e.g., hepatic disorder, renal disorder, cardiovascular disorder, digestive disorder, cancer, allergy) which are inadequate for participating in this study. (2) QTc is over 450 ms of the 12-lead electrocardiogram at screening. (3) Subjects who made blood donation of more than or equal to 400 mL within 12 weeks prior to dosing, or subjects who made component blood donation or blood donation of more than or equal to 200 mL within 4 weeks prior to dosing. (4) Subjects who took any medications or supplements within 4 weeks prior to dosing. (5) Subjects who consumed any foods or drinks containing grapefruits (e.g., juice and/or pulp) within 7 days prior to dosing. (6) Subjects who consumed any foods or drinks containing alcohol or caffeine within 3 days prior to dosing. (7) Subjects who received other investigational agents within 16 weeks prior to dosing. (8) Subjects who engaged in excessive exercise within 3 days prior to dosing. (9) Subjects who do not agree to use appropriate contraception methods for 90 days after dosing. (10) Subjects determined by the investigator to be inadequate for this study for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety of WN1316 in terms of physical examination, adverse events/reactions, laboratory tests before and after of dosing, Vital Signs, 12-lead electrocardiogram. - Pharmacokinetics of WN1316 by assessment of the plasma Cmax, Tmax, T1/2, AUC0-t, AUC0-24, AUC0-inf, CLtot/F, kel, MRT0-t [ pre-dose, 0.5, 1, 2, 3, 5, 7, 10 and 24 hours ] - Pharmacokinetics of WN1316 by assessment of the urine Ae0-t [ 24 hours urine] | — |
Countries
Japan
Contacts
Public ContactEriko Aotani
Kitasato Academic Research Organization, Kitasato University Clinical Trial Coordinating Center
Outcome results
None listed