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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018040
Receipt No. R000020899
Scientific Title 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
Date of disclosure of the study information 2015/06/23
Last modified on 2017/02/24

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Basic information
Public title 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
Acronym An open-label, randomized, study to compare the pharmacokinetic and safety profile of single dose of TAK-070 under fed and fasting condition
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Iwatsubo
Organization The University of Tokyo Hospital
Division name Unit for Early and Exploratory Clinical Development
Zip code
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
1st name
Middle name
Last name Toshio Ga
Organization The University of Tokyo Hospital
Division name Unit for Early and Exploratory Clinical Development
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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