UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018040 |
|---|---|
| Receipt number | 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 18:41:27 |
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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
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
tga-tky@umin.org
Sponsor or person
Institute
Unit for Early and Exploratory Clinical Development,
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020899
