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 - An open-label, randomized, study to compare the pharmacokinetic and safety profile of single dose of TAK-070 under fed and fasting condition

nit for Early and Exploratory Clinical Development, The University of Tokyo Hospital0 sites8 target enrollmentJune 23, 2015

ConditionsAlzheimer&#39 s disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Alzheimer&#39
Sponsor: nit for Early and Exploratory Clinical Development, The University of Tokyo Hospital
Enrollment: 8
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 23, 2015

End Date

November 30, 2015

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

nit for Early and Exploratory Clinical Development, The University of Tokyo Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

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