UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015054 |
|---|---|
| Receipt number | R000017516 |
| Scientific Title | An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis |
| Date of disclosure of the study information | 2014/09/04 |
| Last modified on | 2015/12/25 16:35:40 |
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Basic information
Public title
An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis
Acronym
An investigator initiated clinical trial in healthy adults of WN1316
Scientific 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:Acronym
An investigator initiated clinical trial in healthy adults of WN1316
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis (ALS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety, tolerability and pharmacokinetics in healthy adults who received a single oral dose of WN1316 (60 micrograms, 180 micrograms, 600 micrograms).
Basic objectives2
Others
Basic objectives -Others
Safety/Pharmacokinetics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- 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]
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Placebo (Distilled water) 5 mL is administered single dose orally.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key 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.
Key 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.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Nagashima |
Organization
Clinical Research Hospital Tokyo
Division name
Clinical Research Center
Zip code
Address
NT Building 3F, 3-87-4 Hara-machi, Shinjyuku-ku, Tokyo, Japan
TEL
+81-3-3355-7200
hirotaka.nagashima@crht.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eriko Aotani |
Organization
Kitasato Academic Research Organization, Kitasato University
Division name
Clinical Trial Coordinating Center
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
+81-3-5791-6400
Homepage URL
als-1316@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Clinical Research Hospital Tokyo
Institute
Department
Personal name
Funding Source
Organization
Neugen Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 01 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2015 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017516
