A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects
- Conditions
- Healthy Elderly Adult
- Registration Number
- JPRN-UMIN000010218
- Lead Sponsor
- The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 96
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method