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
- Conditions
- Alzheimer's disease
- Registration Number
- JPRN-UMIN000018040
- Lead Sponsor
- nit for Early and Exploratory Clinical Development, The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 8
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method plasma concentration and pharmacokinetic parameters of TAK-070, M-I and M-II: Cmax, AUC0-24, AUC0-48(if applicable), tmax, t1/2
- Secondary Outcome Measures
Name Time Method safety: clinical examination, vital signs, body weight, laboratory tests, 12-lead ECG and adverse events