Neurosis, somnipathy
Conditions
Interventions
Extensive metabolizers of CYP2C19
Poor metabolizers of CYP2C19
Sponsors
P-One Clinic, Keikokai Medical Corp
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a) Healthy adult male aged 20-35. b) Judged by the doctor to be appropriate as a subject, based on clinical testing and a physical examination at the time of screening and medical history. 4) Body mass index over 18.5 and under 24.9 inclusive at the time of screening. 5) The subject is able to understand and abide by the study protocol, and is willing to provide voluntary consent in writing.
Exclusion criteria
Exclusion criteria: a) Has hypotension (blood pressure of less than 100 mmHg during systole), hypertension (blood pressure of 140 mmHg or higher during systole) or diabetes (HbA1c NGSP 6.5% or higher). b) Has donated or lost over 200 ml (1 unit) of blood within four weeks prior to study drug administration or 400 ml (2 units) within 3 months, or is anemic (less than Hb 12 g/dl). c) Has a serious neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, digestive tract (including digestive tract disorders thought to impact trial drug absorption), respiratory, or metabolic disease in their medical history or as a concomitant condition. d) A clinically serious abnormality has been found by the principal investigator or one of the subinvestigators in the clinical test values, ECG or physical examination. e) Had a clinically serious illness within 30 days prior to study drug administration. f) Has used some sort of health food, grapefruit (including food containing it), or medical product within seven days prior to study drug administration or will use it during the study period. g) Has smoked tobacco or ingested nicotine within 30 days prior to study drug administration and, moreover, cannot abide by the prohibition on smoking during the study period. h) Cannot abide by the ban on caffeine and alcohol during the study period. i) Tested positive for a specific abused substance in the urine drug test at the screening. j) Tested positive for either HIV antibodies/antigens, HCV antibodies, or HBs antigens. 15) Anything else that the principal investigator or one of the subinvestigators considers to be disqualifying.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the effect of itraconazole on the pharmacokinetics of etizolam in poor metabolizers of CYP2C19 and compare with extensive metabolizers | — |
Countries
Japan
Outcome results
None listed