臨床研究等提出・公開システム

Date of registration	Mar. 07, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221402

Scientific Title	CS-8958 Clinical Pharmacology study -Evaluation of intrapulmonary pharmacokinetics of CS-8958 and laninamivir after a single inhaled dose of CS-8958 in healthy Japanese subjects -
Public Title	Intrapulmonary Pharmacokinetics of CS-8958

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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.htm
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		35
Study Type		Interventional
Study Design	Study Design	single-center, open, single dose
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- male Japanese - between the age of 20 and 45 - between the BMI of 18.5 and 25.0
	Exclusion Criteria	- Subjects will be excluded if they have a history of lactose, neuraminidase inhibitor, or drugs using bronchoalveolar lavage. - Subjects with abnormal lung function tests will be excluded.
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		healthy volunteers
Intervention(s)		investigational material(s) Generic name etc : CS-8958 INN of investigational material : laninamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : CS-8958 40mg, single inhalation
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Pharmacokinetic parameters for CS-8958 and laninamivir
Secondary Outcome

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

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-111441
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Jan. 23, 2015	Detail	Changes
7	Jan. 23, 2015	Detail	Changes
6	Jan. 23, 2015	Detail	Changes
5	Jan. 21, 2015	Detail	Changes
4	Nov. 09, 2011	Detail	Changes
3	Nov. 09, 2011	Detail	Changes
2	Mar. 07, 2011	Detail	Changes
1	Mar. 07, 2011	Detail

List of change history