UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010218 |
|---|---|
| Receipt number | R000011969 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects |
| Date of disclosure of the study information | 2013/03/12 |
| Last modified on | 2017/02/24 18:31:24 |
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Basic information
Public title
A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects
Acronym
A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects
Scientific Title:Acronym
A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects
Region
| Japan |
Condition
Condition
Healthy Elderly Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety, tolerability, and pharmacokinetic parameters of TAK-070 and its metabolites, M-I and M-II, in healthy elderly subjects in single and multiple dose study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
safety: physical examination, pulmonary function tests, vital signs, prior and concomitant therapy, 12-lead electrocardiogram (ECG), clinical laboratory tests and adverse events (AEs)
Key secondary outcomes
pharmacokinetics: in plasma and urine for TAK-070 and its major
metabolites, M-I and M-II
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
<TAK-070 group>
Single-dose study: to receive a single dose of TAK-070, 10, 25, 50 and 100mg on the Day 1
Multiple-dose study: to receive TAK-070, 10, 25, 50 and 75(100)mg from Day 1 to Day 16 daily.
Interventions/Control_2
<placebo group>
Single-dose study: to receive a single dose of placebo on the Day 1
Multiple-dose study: to receive placebo from Day 1 to Day 16 daily.
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Subjects who meet the following criteria will be included in the study:
a)age: 65 to 80 years old, inclusive.
b)male
c)has a good general condition and can ingest study drugs based on past history and physical examination (in the investigator's opinion).
d)does not consume alcohol and tobacco throughout the duration of the study and caffeine during hospitalization.
e)BMI: 18 to 34, inclusive.
f)can understand and comply with the protocol and has signed the informed consent document at screening.
g)has a negative hepatitis panel including anti-HAV, HBs Ag and anti-HCV and does not have a history and blood biochemical findings of hepatic diseases.
h)has a negative HIV antibody at screening.
Key exclusion criteria
The following subjects will be excluded from the study:
a)a hypersensitivity to TAK-070 or related compounds.
b)was administered TAK-070 in past times or participated in any other clinical trial within 3 months.
c)a history or complication of significant neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease (according to investigator's decision).
d)a history or complication of schizophrenia defined by DSM-IV criteria.
e)a history of delirium, paranoia, bipolar disorder or depression within the past 5 years
f)any clinically important abnormal finding in physical examination, ECGs or clinical laboratory tests.
g)a clinically significant illness within 30 days before in hospital (Day -3).
h)took disallowed medications within 14 days before the study drug administration or continues to take them during the study.
i)took OTC medication, including St. John's Wort, gingko biloba, or nutraceuticals, within 7 days of study drug administration or continues to take during the study.
j)has consumed tobacco, nicotine or alcohol within 30 days before study drug administration and is not capable of complying with no smoking and no drinking during the study.
k)a history of alcohol abuse defined by DSM-IV criteria within a year of screening or is an addicted drinker.
l)positive urine tests for selected substances of abuse, including alcohol, at screening.
m)clinical findings of active hepatic disease or ALT/AST exceeds 1.5 times of upper limits of normal level.
n)made a blood donation or loses blood more than 200mL within 30 days before the screening.
o)makes a blood donation during the duration of the study or within 4 weeks after the study.
p)would not be 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, or is judged not to carry the trial through by principal investigator or sub-investigator.
Target sample size
96
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, 113-0033, Japan
TEL
+81-3-5800-8855
iwatsubo@m.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
+81-3-5800-9083
Homepage URL
tga-tky@umin.org
Sponsor or person
Institute
The University of Tokyo Hospital
Unit for Early and Exploratory Clinical Development
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants
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)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 12 | 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
| 2012 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 04 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | 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=R000011969
