Healthy Elderly Adult
Conditions
Interventions
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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.
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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.
Sponsors
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety: physical examination, pulmonary function tests, vital signs, prior and concomitant therapy, 12-lead electrocardiogram (ECG), clinical laboratory tests and adverse events (AEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics: in plasma and urine for TAK-070 and its major metabolites, M-I and M-II | — |
Countries
Japan
Contacts
Public ContactToshio Ga
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Outcome results
None listed