臨床研究等提出・公開システム

Date of registration	June. 05, 2017
Last modified on	May. 20, 2020
Trial ID	jRCT1080223551

Scientific Title	Clinical Pharmacology Study of DS-5058b Immediate-release and Extended-release Tablets in Healthy Japanese Subjects
Public Title	Clinical Pharmacology Study of DS-5058b Immediate-release and Extended-release Tablets in Healthy Japanese Subjects

Completion Date or Terminated date	July. 17, 2017
Actual Enrolled Number	36
Baseline Characteristics	The subject demographics and characteristics for the safety analysis set was similar to those for the pharmacokinetic analysis set.
Participant flow	A total of 36 subjects who were confirmed to be eligible were enrolled after obtaining informed consent for the study. Three subjects withdrew from the study.
Adverse events	- Treatment emerged adverse events (TEAEs) were reported in 14 of 9 subjects in the study. - No death nor serious adverse event was reported. - TEAEs leading to study discontinuation occurred in 3 subjects. The events were assessed as being related to the treatment because potential association could not be denied. - No clinically relevant changes from baseline were seen in laboratory parameters, vital signs, 12-lead ECG parameters, or body weight, except for the abnormal change in the laboratory values reported as TEAEs. In addition, there was no concern related to the drug dependency.
Primary Outcome Measures	- After the administration of DS-5058 IR tablets under fasting conditions, the mean Cmax and AUClast of oxycodone in plasma were 13.7 ng/mL, and 65.1 ngh/mL, respectively. The median Tmax was 1.00 h. Under fed conditions, the mean Cmax and AUClast were 14.8 ng/mL and 67.8 ngh/mL, respectively. The median Tmax was 0.75 h. - After the administration of DS-5058 ER tablets under fasting conditions, the mean Cmax and AUClast were 13.6ng/mL and 144 ngh/mL, respectively. The median Tmax was 3.50 h. Under fed conditions, the mean Cmax and AUClast were 16.5 ng/mL, and 152 ngh/mL, respectively. The median Tmax was 4.50 h.
Secondary Outcome Measures	Please refer to "adverse events" section since secondary outcome measures in the study are safety.
Brief summary	After the administration of DS-5058 IR tablet, oxycodone was rapidly absorbed in both fasting and fed conditions, confirming the characteristics of the immediate release formulation. After the administration of DS-5058 ER tablet, Tmax of oxycodone in plasma was around 4 h in both fasting and fed conditions, confirming the characteristics of the extended-release formulation. There were no safety concerns associated with single oral doses of 5 mg DS-5058b IR and 10 mg ER tablets.
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	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		June. 14, 2017
Target Sample Size		36
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, single-dose study.
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Japanese male -Between the age of 20 and 45 -Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2
	Exclusion Criteria	-Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) -People with drug or alcohol dependence. etc
	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 : DS-5058b INN of investigational material : Oxycodone hydrochloride hydrate Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Single oral dose of DS-5058b immediate-release tablet 5 mg or extended-release tablet 10 mg control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacokinetics -Pharmacokinetics
Secondary Outcome		safety -Safety

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	-
Address	-
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	June. 02, 2017

Secondary ID No.	JapicCTI-173606
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	May. 20, 2020	(this page)	Changes
5	Dec. 17, 2018	Detail	Changes
4	April. 20, 2018	Detail	Changes
3	April. 20, 2018	Detail	Changes
2	June. 05, 2017	Detail	Changes
1	June. 05, 2017	Detail

List of change history