臨床研究等提出・公開システム

Date of registration	July. 20, 2020
Last modified on	Oct. 12, 2022
Trial ID	jRCT1080225285

Scientific Title	A Phase I Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-S-600918 Following Oral Dose Administration in Healthy Adult Male Subjects
Public Title	Mass Balance Study of [14C]-S-600918 Oral Suspension in Healthy Male Subjects

Completion Date or Terminated date	Sept. 09, 2020
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	No
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	Shionogi & Co., Ltd.
	Address
	Phone Number	+81-6-6209-7885
	E-mail Address	shionogiclintrials-admin@shionogi.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Shionogi & Co., Ltd.
	Address
	Phone Number	+81-6-6209-7885
	E-mail Address	shionogiclintrials-admin@shionogi.co.jp

Recruitment Status	completed

Date of First Enrolment		Aug. 20, 2020
Target Sample Size		6
Study Type		Interventional
Study Design	Study Design	Single-centre, open-label, single arm
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male subjects
	Exclusion Criteria	Subjects who are considered ineligible for this study by the investigator or subinvestigator due to current or history of clinically significant metabolic or endocrine, cardiovascular, renal, hepatic, hematological, urological, immunological, pulmonary, respiratory or gastrointestinal disease, neurological or psychiatric disorderor, or other clinically significant diseases.
	Minimum Age	30age old over
	Maximum Age	65age old under
	Gender	Male
Health Condition or Problem Studied		Healthy subjects
Intervention(s)		investigational material(s) Generic name etc : S-600918 INN of investigational material : sivopixant Therapeutic category code : 222 Antitussives Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacokinetics - Total radioactivity (TR) in all excreta (urine and faeces): Cumulative amount of TR excreted in excreta (CumAe) and CumAe expressed as a percentage of the radioactive dose administered (Cum%Ae) - Concentrations of TR in whole blood and plasma - Pharmacokinetics (PK) parameters for TR, S-600918 and S-600918 acyl glucuronide in plasma for TR in whole blood including but not limited to: time to maximum concentration (Tmax), maximum concentration (Cmax), and area under the concentration-time curve (AUC)
Secondary Outcome		safety pharmacokinetics - Amount of TR excreted in excreta (Ae) and Ae expressed as a percentage of the radioactive dose administered (%Ae), CumAe and Cum%A by interval in urine, faeces, and urine and faeces combined, and appropriate PK parameters of TR, S-600918 and S-600918 acyl glucuronide in plasma and TR in whole blood. - Each metabolite accounting for more than 5% (in plasma) by AUC of circulating TR and each metabolite in excreta (urine and faeces) that account for more than 10% of the administered radioactive dose - Whole blood:plasma concentration ratios for TR. - Adverse events (AEs), vital signs, ECGs, physical examinations and laboratory safety tests.

Primary Sponsor	Shionogi B.V.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	Health and Social Care Research Ethics Committee A
Address	Office for Research Ethics Committees in Northern Ireland (ORECNI), Business Services Organisation, Lissue Industrial Estate West, Rathdown Walk, Moira Road, Lisburn, Co. Antrim, BT28 2RF
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	July. 14, 2020

Secondary ID No.	JapicCTI-205381
Name of Other Registries

Countries / Regions of Recruitment	Europe

History of Changes

No	Publication date
4	Oct. 12, 2022	(this page)	Changes
3	Nov. 12, 2021	Detail	Changes
2	Oct. 16, 2020	Detail	Changes
1	July. 20, 2020	Detail

List of change history