Alzheimer'
Conditions
Interventions
Fasted single dosing of TAK-070 50mg followed by fed single dosing of TAK-070 50mg
Fed single dosing of TAK-070 50mg followed by fasted single dosing of TAK-070 50mg
Sponsors
Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Participants may be included in the study only if they meet all of the following criteria: 1. are Japanese healthy adult males between the ages of 20 to 35 who have a body mass index of over 18.5 kg/m2, under 25.0 kg/m2 2. are considered that their conditions are good based on medical history and the physical examination, and who are judged capable of taking investigational products orally by the investigator 3. do not consume alcohol and tobacco throughout the duration of the study, nor caffeine during the hospitalization 4. are capable of understanding and complying with the protocol and willing to sign the informed consent form 5. on the screening visit, are negative results of HIV antigen-antibody, hepatitis screening (including HBsAg and anti-HCV) and syphilis test (including STS and TPHA), and do not have any medical histories of the hepatic diseases and syphilis, and blood biochemical findings
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration and pharmacokinetic parameters of TAK-070, M-I and M-II: Cmax, AUC0-24, AUC0-48(if applicable), tmax, t1/2 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety: clinical examination, vital signs, body weight, laboratory tests, 12-lead ECG and adverse events | — |
Countries
Japan
Contacts
Public ContactToshio Ga
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Outcome results
None listed