Unique ID issued by UMIN | UMIN000027063 |
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Receipt number | R000031023 |
Scientific Title | Pharmacokinetic assessment of a six-probe cocktail for OATPs and CYPs for elderly and non-elderly subjects |
Date of disclosure of the study information | 2017/04/19 |
Last modified on | 2017/04/19 13:31:25 |
Pharmacokinetic assessment of a six-probe cocktail for OATPs and CYPs for elderly and non-elderly subjects
Pharmacokinetic assessment of a six-probe cocktail for OATPs and CYPs for elderly and non-elderly subjects
Pharmacokinetic assessment of a six-probe cocktail for OATPs and CYPs for elderly and non-elderly subjects
Pharmacokinetic assessment of a six-probe cocktail for OATPs and CYPs for elderly and non-elderly subjects
Japan |
healthy male
Adult |
Others
YES
1) to evaluate the effects of age on the pharmacokinetics of substrates (telmisartan, atorvastatin, valsartan, alprazolam, pitavastatin and chlorzoxazone)
2) to evaluate the effects of the polymorphisms of OATPs and CYPs in elderly subjects
3) to explore the surrogate markers that reflect the functions of OATPs and CYPs
Pharmacokinetics
1) pharmacokinetics of telmisartan, atorvastatin, valsartan, alprazolam, pitavastatin and chlorzoxazone
2) the plasma and urine concentrations of endogenous compounds
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
substrate cocktail
20 | years-old | <= |
80 | years-old | > |
Male
The investigators must ensure that all subjects being considered meet the following
inclusion criteria:
1) Japanese healthy male who is capable to understand and sign the informed consent
2) 20-45 (non-elderly) or 65-79 (elderly) years of age
3) BMI 17.6-26.4
4) good health as determined by physical examination, vital signs and laboratory tests.
The investigators must ensure that all subjects being considered meet the following
exclusion criteria or conditions:
1) history of allergy to any drugs
2) medical attention within 2 months prior to participation
3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
4) donation of 400 mL or more of blood within 12 weeks prior to participation
5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity
6) history of drug abuse
7) alcohol abuse.
8) lactose intolerance
9) taking drugs or healthy foods which may affect drug metabolism
16
1st name | |
Middle name | |
Last name | Shunji Matsuki |
LTA
Fukuoka Mirai Hospital
3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
092-662-3608
shunji-matsuki@lta-med.com
1st name | |
Middle name | |
Last name | Miyuki Kimura |
LTA
Fukuoka Mirai Hospital
3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
092-662-3608
miyuki-kimura@lta-med.com
Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University
Public funds
Other
NO
2017 | Year | 04 | Month | 19 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 15 | Day |
2016 | Year | 01 | Month | 01 | Day |
2017 | Year | 04 | Month | 19 | Day |
2017 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031023
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