臨床研究等提出・公開システム

Date of registration	Dec. 19, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222333

Scientific Title	Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects
Public Title	Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Nihon Medi-Physics Co., Ltd.
	Address	masahiro_omote@nmp.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Nihon Medi-Physics Co., Ltd.
	Address	03-5634-7434
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		6
Study Type		Interventional
Study Design	Study Design	uncontrolled, single-dose, open-label
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Body weight: 50.0 kg or more -Body mass index: 18.5 and more - 25.0 below
	Exclusion Criteria	-Subjects with abnormality found by liver function test or renal function test. -Subjects with a hypersensitive history to drugs or foods. -Subjects who have abused or are abusing drugs. -Subjects who were or are addicted to alcohol. -Subjects who have received an investigational new drug other than NMK20 from six months before screening up to hospital admission. etc.
	Minimum Age	20age old over
	Maximum Age	64age old under
	Gender	Male
Health Condition or Problem Studied		Healthy Japanese male subjects
Intervention(s)		investigational material(s) Generic name etc : NMK20 INN of investigational material : - Therapeutic category code : 43- Radioactive medicines Dosage and Administration for Investigational material : Intravenous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety Assessment of subjective/objective symptoms, electrocardiogram exams, vital signs, clinical tests
Secondary Outcome		Pharmacokinetics and exposed dose Pharmacokinetics: 1) Assessment of radioactivity in blood, radioactivity distribution rate in organs/tissue and urinary excretion rate of radioactivity 2) Assessment of unchanged drug and radioactive metabolites in blood plasma and urine Exposed dose: Calculation of exposed dose by medical internal radiation dose(MIRD) method

Primary Sponsor	Nihon Medi-Physics Co., Ltd.
Secondary Sponsor

Name of Funding Organization	Nihon Medi-Physics Co., Ltd.
Name of Research Funding

Name of Funding Organization
Name of Research Funding	None

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-132383
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Nov. 14, 2014	Detail	Changes
9	Nov. 14, 2014	Detail	Changes
8	June. 25, 2014	Detail	Changes
7	June. 25, 2014	Detail	Changes
6	April. 02, 2014	Detail	Changes
5	April. 02, 2014	Detail	Changes
4	Jan. 29, 2014	Detail	Changes
3	Jan. 29, 2014	Detail	Changes
2	Dec. 19, 2013	Detail	Changes
1	Dec. 19, 2013	Detail

List of change history