Unique ID issued by UMIN | UMIN000025104 |
---|---|
Receipt number | R000028410 |
Scientific Title | Phase I study of PSO17 for healthy volunteers |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2018/06/03 20:13:18 |
Phase I study of PSO17 for healthy volunteers
Phase I study of PSO17
Phase I study of PSO17 for healthy volunteers
Phase I study of PSO17
Japan |
healthy subjects
Radiology | Adult |
Others
NO
Safety of O-17 labeled water (PSO17) is evaluated in healthy male volunteers. Measurement of pharmacokinetis and MRI signal of O-17 labeled water (PSO17) are also conducted.
Safety
Exploratory
Others
Phase I
1) Evaluation of adverse effect and medically significant change (vital signs) until Day 8 or study suspension
2) laboratory tests (blood tests and urinary tests) at day 2, compared to the baseline
1) blood concentration of H2-17O from imidiate after the administration to Day 8 or study suspension (Cmax, Tmax, AUC, and T1/2)
2) MRI signal change of PSO17
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Diagnosis
Medicine |
Intravenous administration of PSO17 (single administration, 10% or 20%, 1mL/kg)
Placebo (normal saline)
20 | years-old | <= |
40 | years-old | > |
Male
(1) Japanese healthy male
(2) BMI 18.5-25.0, Body weight < 60kg
(3) age 20-40
(4) agreement of medically appropriate contraception
(5) informed consent is obtained after the sufficient explanation of this study
(1) metallic implant (except for conditinally usage devices for MRI scan) , tattoo, or claustrophobia
(2) positive MRI findings at pre-observation period (except for doctors aproval)
(3) CNS, liver, kidney or heart disease
(4) drug allergy
(5) long term intake of drugs over 30 days
(6) other clinical trials within 90 days
(7) significant signs and symptoms (ex. headache, acute infections) within 30 days
(8) unexpected values in laboratory tests at pre-observation or preceding period
(9) loss of blood (>400 mL) within 12 weeks before the registration, or loss of blood (>200 mL) within 4 weeks before the registration, or blood donation within 2 weeks
(10) employees or families of this institute, or who agrees under the compulsion
(11) contraindicated for this study due to other reasons
12
1st name | |
Middle name | |
Last name | Kohsuke Kudo |
Hokkaido University Hospital
department of diagnostic and interventional radiology
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
011-706-5977
kkudo@huhp.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Kohsuke Kudo |
Hokkaido University Hospital
department of radiology
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
011-706-5977
kkudo@huhp.hokudai.ac.jp
Hokkaido University Hospital
Japan Agency for Medical Research and Development (AMED)/Translational Research Network Program
Japanese Governmental office
Japan
NO
北海道大学病院(北海道)
2016 | Year | 12 | Month | 01 | Day |
Partially published
Indirect proton MRI can be used for the measurement of 17O. We evaluated the safety and feasibility of 17O-labeled water. No adverse effects were seen, and the measured concentrations were proportional to the injection dose. 17O-labeled water may be used for safe tracer of blood flow.
Completed
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 01 | Month | 11 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2016 | Year | 12 | Month | 01 | Day |
2018 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028410
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |