臨床研究等提出・公開システム

Date of registration	April. 04, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221755

Scientific Title	A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects
Public Title

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	Eli Lilly Japan K.K.
	Address	0120-360-605
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	[Inclusion Criteria] * Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product. * Have a body mass index (BMI) of 18.5 to 29.9kg/m^2, inclusive, at the time of screening. * Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.
	Exclusion Criteria	[Exclusion Criteria] * Poor metabolizers of enzyme Cytochrome P450 2D6 (CYP2D6) (assessed at screening). * Have an abnormality in the 12-lead Electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT(QTcB) intercal >450 millisecounds (msec). * Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS). * Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Male
Health Condition or Problem Studied		Healthy Volumteer
Intervention(s)		investigational material(s) Generic name etc : LY110140 INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : [SD part] 5mg, 20mg, or 40mg LY110140 will be administered once in the fasted state on Day 1. [MD part] 20mg or 40mg LY110140 will be administered once daily oral dosing for 28 consecutive days. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : [MD part] Placebo will be administered once daily oral dosing for 28 consecutive days.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Eli Lilly Japan K.K.
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-121797
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Sept. 05, 2013	Detail	Changes
3	Sept. 05, 2013	Detail	Changes
2	April. 04, 2012	Detail	Changes
1	April. 04, 2012	Detail

List of change history