臨床研究等提出・公開システム

Date of registration	June. 04, 2019
Last modified on	June. 30, 2021
Trial ID	jRCT2080224712

Scientific Title	A phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of OPC-131066 Administered in a Randomized, Parallel-group, Placebo-controlled, Double-blind Fashion and Evaluating the Food Effect on the Safety and Pharmacokinetics of OPC-131066 Administered in an Open-label, Crossover Fashion to Healthy Adult Male Subjects
Public Title	A phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics and the Food Effect on the Safety and Pharmacokinetics of OPC-131066

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Otsuka Pharmaceutical Co., LTD.
	Address	-
	Phone Number	-
	E-mail Address	CL_OPCJ_RDA_Team@otsuka.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Otsuka Pharmaceutical Co., LTD.
	Address	-
	Phone Number	+81-3-6361-7314
	E-mail Address

Recruitment Status	terminated

Date of First Enrolment		June. 17, 2019
Target Sample Size		122
Study Type		Interventional
Study Design	Study Design	a randomized, parallel-group, placebo-controlled, double-blind fashion
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Individuals with body mass index (BMI = body weight [kg]/[height{m}]2) of 18.5 kg/m2 to 25.0 kg/m2 (at screening)
	Exclusion Criteria	1) Clinically significant abnormalities found on screening examinations (eg,a marked deviation from the normal range) or from the subject's history and such abnormalities may potentially pose a risk to the subject or affect such variables as absorption, distribution, metabolism, and elimination of the drugs in the opinion of the investigator or subinvestigator. These abnormalities include but are not limited to cardiac, hepatic, renal, neurological, gastrointestinal, respiratory, hematological, and immunological conditions or their history. 2) Systolic blood pressure of over 140 mmHg or under 100 mmHg or diastolic blood pressure of over 90 mmHg or under 50 mmHg at rest for at least 3 minutes in the supine position, with a decrease in blood pressure upon standing (standing systolic blood pressure- supine systolic blood pressure) of over 20 mmHg at screening. 3) Pulse rate outside the range of 50 to 90 bpm at rest for at least 3 minutes in the supine position at screening. 4) Clinically significant electrocardiographic(ECG) findings from a 12-lead ECG examination performed at screening (Parts A, B, and C)For example, atrioventricular block, QRS interval of over 120 msec, and QTcF interval of over 450 msec.
	Minimum Age	20age old over
	Maximum Age	39age old under
	Gender	Male
Health Condition or Problem Studied		healthy adult
Intervention(s)		investigational material(s) Generic name etc : OPC-131066 INN of investigational material : - Therapeutic category code : 213 Diuretics Dosage and Administration for Investigational material : A single dose of OPC-131066 will be orally administered at 0.5, 1, 2, 4, 8, 16, 32, 64, 96, and 128 mg to subjects control material(s) Generic name etc : placebo 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		safety Adverse events (AEs)
Secondary Outcome		safety pharmacokinetics pharmacodynamics pharmacogenomics laboratory test

Primary Sponsor	Otsuka Pharmaceutical Co., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Hakata Clinic Institutional Review Board
Address of IRB	6-18 tenyamachi hakata-ku fukuoka-shi fukuoka
Phone Number of IRB	+81-92-283-7701
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	May. 31, 2019

Secondary ID No.	JapicCTI-194788
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	June. 30, 2021	(this page)	Changes
2	June. 08, 2020	Detail	Changes
1	June. 05, 2019	Detail

List of change history