Pharmacogenomics
Conditions
Interventions
Extensive metabolizers among those with CYP2C19 genetic polymorphism
Intermediate metabolizers among those with CYP2C19 genetic polymorphism
Poor metabolizers among those with CYP2C19 genetic polymorp
Sponsors
P-One Clinic, Keikokai Medical Corp
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Over the age of 20 and under the age of 55 inclusive at the time of consent. 2) Body weight 40 kg or above. 3) Judged by the doctor in charge of the trial to be appropriate, based on clinical testing and a physical examination at the time of screening and medical history. 4) Body mass index is over 18.5 and under 24.9 inclusive at the time of the screening. 5) Is willing to provide voluntary consent in writing.
Exclusion criteria
Exclusion criteria: 1) Has a drug allergy to tacrolimus or voriconazole. 2) Regularly takes some kind of medication. 3) Is anemic (less than Hb 12 g/dL). 4) Has hypotension (blood pressure of less than 100 mmHg during systole) or hypertension (blood pressure of 140 mmHg or higher during systole). 5) Has diabetes (HbA1c (NGSP) 6.5% or higher). 6) Has a serious neurological, cerebrovascular, cardiovascular, respiratory, hepatic, renal, endocrine or metabolic disease. 7) Has a digestive tract disorder of the sort that impacts absorption of drugs taken orally. 8) Has donated or lost over 200 ml (1 unit) of blood within four weeks or 400 ml (2 units) within three months prior to study drug administration. 9) Contracted a clinically serious illness within four weeks prior to study drug administration. 10) Has smoked tobacco (including ingestion of nicotine) within four weeks prior to study drug administration and, moreover, cannot abide by the prohibition on smoking during the study period. 11) Has ingested some sort of nutritional supplement, health food, grapefruit (including food containing it), or medical product within one week prior to study drug administration. 12) Cannot abide by the ban on consumption of caffeine and alcohol starting two days before hospitalization until the follow-up examination. 13) Tested positive for a specific abused substance in the urine drug test at the screening. 14) Tested positive for either HIV antibodies/antigens, HCV antibodies, or HBs antigens. 15) Anything else that the doctor in charge judges to be disqualifying.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in the blood concentration of tacrolimus when coadministered with voriconazole and when administered alone in extensive metabolizers (EM), intermediate metabolizers (IM) and poor metabolizers (PM) of CYP2C19 | — |
Countries
Japan
Outcome results
None listed