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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000015054
• Date of registration: 04/09/2014
• Prospective Registration: Yes
• Primary sponsor: Clinical Research Hospital Tokyo
• Public title: An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis
• Scientific title: An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis - An investigator initiated clinical trial in healthy adults of WN1316
• Date of first enrolment: 2014/09/21
• Target sample size: 24
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017516
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Eriko Aotani
• Affiliation: Kitasato Academic Research Organization, Kitasato University Clinical Trial Coordinating Center

• Name: Hirotaka Nagashima
• Affiliation: Clinical Research Hospital Tokyo Clinical Research Center

Key inclusion & exclusion criteria

Inclusion 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.

Age minimum: 20years-old
Age maximum: 35years-old
Gender: Male

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Intervention(s)

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 administered single dose orally.

Primary Outcome(s)

- 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]

Source(s) of Monetary Support

Neugen Pharma Inc.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 26/10/2014