UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of PSO17 for healthy volunteers
Title of the study (Brief title)	Phase I study of PSO17
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase I

Assessment
Primary outcomes	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
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of PSO17 (single administration, 10% or 20%, 1mL/kg)
Interventions/Control_2	Placebo (normal saline)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	(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
Key exclusion criteria	(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
Target sample size	12

Research contact person
Name of lead principal investigator	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	department of diagnostic and interventional radiology
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5977
Email	kkudo@huhp.hokudai.ac.jp

Public contact
Name of contact person	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	department of radiology
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5977
Homepage URL
Email	kkudo@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)/Translational Research Network Program
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 11 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	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.
Other related information

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2018 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028410