UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016626 |
|---|---|
| Receipt number | R000019305 |
| Scientific Title | Clinical pharmacokinetic study of NIG-0392 on healthy adults. |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2016/03/25 09:09:53 |
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Basic information
Public title
Clinical pharmacokinetic study of NIG-0392 on healthy adults.
Acronym
Clinical pharmacokinetic study of NIG-0392 on healthy adults.
Scientific Title
Clinical pharmacokinetic study of NIG-0392 on healthy adults.
Scientific Title:Acronym
Clinical pharmacokinetic study of NIG-0392 on healthy adults.
Region
| Japan |
Condition
Condition
prevent and lower internal exposure of thyroid caused by radioiodine.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of blood iodine kinetics and safety of NIG-0392, potassium iodine, and non-administration.
Examination of excretion amount of urinary iodine used as reference.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
plasma iodine concentration
safety
Key secondary outcomes
urinary iodine concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
NIG-0392
Interventions/Control_2
Potassium iodine
Interventions/Control_3
Non-administration
(no medicine, water only)
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Healthy male subjects between the ages of 20 to 40 years when at informed consent.
2) Body weight between 50 and 80 kg
3) Body Mass Index between 18.5 to 25.0 kg/m2
4) Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during screening. Some of the laboratory values e.g complete blood count etc that is out of the normal or reference range will be carefully considered by the clinical investigator.
5) Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria
1) History of hypersensitivity for any elements involved in all the investigational agents in this study
2) Tuberculosis patient
3) Hyperthyroid patient
4) Hypothyroid patient
5) Renal dysfunction
6) Myotonia congenita
7) Hyperkalemia
8) Subjects who have history of hypocomplementemic urticarial vasculitis
9) Subjects who have history of hypersensitivity for iodine contrast agent
10) Subjects who have history of dermatitis herpetiformis Duhring
11) Subjects who take upper gastrointestinal endoscopy in the term from screening test to one week after administration.
12) Serological reaction of syphilis, HBsAg, HCVAb or HIVAb positive
13) AST(GOT) or ALT(GPT): more than the reference value by screening or clinical assay before the administration in each term(excluding the case of AST or ALT value within the standard value by reexamination)
14) Subjects who have present or past history of cardiovascular system, immune system, hematologic, brain vasculature, respiratory system, digestive system, liver or renal disease
15) History of gastrointestinal tract surgery which has an effect on the drug absorption such as gastrectomy, gastrointestinal suture, or intestinal resection
16) Presence of alcohol or drug dependency
17) Subjects who need some cure for actual allergic symptom, such as asthma, pollinosis, or atopic dermatitis
18) Subjects who use other medicine in the week prior to hospitalization of 1st period or need to take other medicine during the test (including external preparation etc.)
19) Enrolled in another investigational study and took other investigational drug within 4 months(if it is a patch test, within one month)
20) Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood content within 2 weeks prior to the time of consent.
21) Subjects who are judged ineligible for entry to this study by the study physician
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Moritoyo |
Organization
The University of Tokyo Hospital
Division name
Unit for Early and Exploratory Clinical Development Phase 1 Unit, Clinical Research Support Center
Zip code
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo 113-8655,Japan
TEL
03-5800-9083
moritoyo-tky@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Yamashiro |
Organization
Nichi-Iko Pharmaceutical Co., Ltd.
Division name
Dept. of Clinical Study
Zip code
Address
205-1 Shimoumezawa, Namerikawa City, Toyama Prefecture, Japan
TEL
076(475)5767
Homepage URL
takuro-yamashiro@nichiiko.co.jp
Sponsor or person
Institute
Nichi-Iko Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 25 | 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
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
| 2015 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 25 | Day |
Last modified on
| 2016 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019305
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