UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label, randomized, two-period crossover study to compare the pharmacokinetic and safety profile of single dose of TAK-070 (50 mg) under fed and fasting condition in healthy volunteer
Title of the study (Brief title)	An open-label, randomized, study to compare the pharmacokinetic and safety profile of single dose of TAK-070 under fed and fasting condition
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the pharmacokinetics and safety in healthy males who received TAK-070 50mg in fed versus fasted condition
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	plasma concentration and pharmacokinetic parameters of TAK-070, M-I and M-II: Cmax, AUC0-24, AUC0-48(if applicable), tmax, t1/2
Key secondary outcomes	safety: clinical examination, vital signs, body weight, laboratory tests, 12-lead ECG and adverse events

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Fasted single dosing of TAK-070 50mg followed by fed single dosing of TAK-070 50mg
Interventions/Control_2	Fed single dosing of TAK-070 50mg followed by fasted single dosing of TAK-070 50mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Male
Key inclusion criteria	Participants may be included in the study only if they meet all of the following criteria: 1. are Japanese healthy adult males between the ages of 20 to 35 who have a body mass index of over 18.5 kg/m2, under 25.0 kg/m2 2. are considered that their conditions are good based on medical history and the physical examination, and who are judged capable of taking investigational products orally by the investigator 3. do not consume alcohol and tobacco throughout the duration of the study, nor caffeine during the hospitalization 4. are capable of understanding and complying with the protocol and willing to sign the informed consent form 5. on the screening visit, are negative results of HIV antigen-antibody, hepatitis screening (including HBsAg and anti-HCV) and syphilis test (including STS and TPHA), and do not have any medical histories of the hepatic diseases and syphilis, and blood biochemical findings
Key exclusion criteria	Participants will be excluded from the study if they meet any of the following criteria: 1. are persons who have previously received TAK-070 or participated in other clinical trial or PMS study within 3 months 2. are persons who have clinically significant disease and are not considered healthy by the investigator as a result of clinical examination, vital signs (blood pressure, pulse rate and temperature), 12-lead ECG and clinical examination on the screening visit, or are not suitable for the participation judging from the medical history 3. history or presence of gastrointestinal, hepatic or renal disease known to affect absorption, distribution, metabolism and excretion 4. history or presence of schizophrenia defined by DSM-IV criteria 5. history of delirium, paranoia, bipolar disorder or depression within the past 5 years 6. took an incompatible drug including the OTC (including St. John's Wort, gingko biloba, or nutraceuticals) within 14 days of the administration for the study, or keep taking it during the study 7. has consumed tobacco, nicotine or alcohol since the screening visit and are not capable of complying with no smoking and no drinking during the study 8. history of alcohol abuse defined by DSM-IV criteria within a year of screening visit or are addicted drinker 9. positive findings on urinary drug screening on the screening visit 10. made a blood donation or loses blood more than 200mL within 30 days before the screening visit 11. are not willing to comply with the protocol, be hospitalized at the trial site during the study or cooperate with principal investigator, sub-investigator or clinical cooperator, nor capable of carrying through the trial judging from the investigators
Target sample size	8

Research contact person
Name of lead principal investigator	Takeshi Iwatsubo
Organization	The University of Tokyo Hospital
Division name	Unit for Early and Exploratory Clinical Development
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL	03-5800-8855
Email	iwatsubo@mol.f.u-tokyo.ac.jp

Public contact
Name of contact person	Toshio Ga
Organization	The University of Tokyo Hospital
Division name	Unit for Early and Exploratory Clinical Development
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL	03-5800-9083
Homepage URL
Email	tga-tky@umin.org

Sponsor
Institute	Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院(東京都) The University of Tokyo Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 29 Day
Anticipated trial start date	2015 Year 08 Month 15 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 01 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 23 Day
Last modified on	2017 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020899