An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis (ALS)

• Registration Number: JPRN-UMIN000015054
• Lead Sponsor: Clinical Research Hospital Tokyo

Brief Summary

Oral doses of WN1316 were well tolerated in Japanese healthy male subjects up to 600 micrograms/body (equivalent to the 10 micrograms/kg/day minimum effective dose on ALS mouse model) and no significant safety issue was not observed. In regards to pharmacokinetics, it was confirmed that WN1316 was absorbed and excreted from the body but linearity could not be confirmed owing to too small doses.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-04
• Study Completion: 2014-10-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- 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]