UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046915 |
|---|---|
| Receipt number | R000053479 |
| Scientific Title | A phase I clinical pharmacology study of OPF-105 in healthy adult male |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2022/02/15 09:15:40 |
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Basic information
Public title
A phase I clinical pharmacology study of OPF-105 in healthy adult male
Acronym
A clinical pharmacology study of OPF-105
Scientific Title
A phase I clinical pharmacology study of OPF-105 in healthy adult male
Scientific Title:Acronym
A clinical pharmacology study of OPF-105
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and blood levels of ingredient-related parameters
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (Clinical laboratory tests, Vital signs, Subjective symptoms/objective findings, Physical examination, and Electrocardiography)
Key secondary outcomes
Ingredient-related parameters (Clinical laboratory tests)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
OPF1 group (OPF-105, 550 mL, 2 hours)
Interventions/Control_2
BFI1 group (BFI, 500 mL, 2 hours)
Interventions/Control_3
OPF2 group (OPF-105, 1100 mL, 4 hours)
Interventions/Control_4
BFI2 group (BFI, 1000 mL, 4 hours)
Interventions/Control_5
OPF3 group (OPF-105, 2200 mL, 8 hours)
Interventions/Control_6
BFI3 group (BFI, 2000 mL, 8 hours)
Interventions/Control_7
OPF4 group (OPF-105, 2200 mL/day x 3days, 8 hours/day x 3days)
Interventions/Control_8
BFI4 group (BFI, 2000 mL/day x 3days, 8 hours /day x 3days)
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Those who aged 20 or over to under 40 at the time of obtaining consent
(2) Those who are observed no abnormalities in both arms and are able to establish peripheral venous access
(3) Those whose body mass index is 18.5 or more and less than 30.0
(4) Those who provided written informed consent
Key exclusion criteria
(1) Those who have gastrointestinal, hepatic, renal, cardiovascular, blood, endocrine, and lipid metabolism abnormalities (including a history of these) and are determined to be difficult to participate in the clinical trial by the principal investigator or sub-investigator
(2) Those who are determined not to be suitable as a participant of the clinical trial by the principal investigator or sub-investigator based on the subjective symptoms/objective findings, vital signs, or observation/measurement results of clinical tests
(3) Those who tested positive for infectious diseases (hepatitis B, hepatitis C, HIV, or syphilis)
(4) Those who have a history of hypersensitivity to the ingredients of the test or control solutions
(5) Those who underwent blood sampling or participated in blood donation of more than 200 mL within 4 weeks before the informed consent was obtained
Those who underwent blood sampling or participated in blood donation of more than 400 mL, within 12 weeks before the day of obtaining informed consent
(6) Those who participated in a clinical trial or clinical study and received a drug within 16 weeks before the day of obtaining informed consent
(7) Those who have a history or presence of alcohol or drug abuse
(8) Those who used drugs (including over-the-counter drugs) and consumed foods with health claims (those judged by the principal investigator or sub-investigator to affect this trial) within 2 weeks before the participant registration date
(9) Those who are determined not to be suitable as a participant of the clinical trial by the principal investigator or sub-investigator for any other reasons
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kawauchi |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Clinical Development Department, Research and Development Center
Zip code
101-0052
Address
Nikko Kanda Bldg. 5F, 1-1 Kanda-Ogawamachi Chiyoda-ku Tokyo, Japan
TEL
03-5280-2721
Kawauchi.Yoshiyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Katayose |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Clinical Development Department, Research and Development Center
Zip code
101-0052
Address
Nikko Kanda Bldg. 5F, 1-1 Kanda-Ogawamachi Chiyoda-ku Tokyo, Japan
TEL
03-5280-2721
Homepage URL
Katayose.Satoshi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Factory, Inc.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The IRB of Kitasato University Shirokane Campus
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
Tel
03-5791-6177
irb-pt@insti.kitasato-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
This study protocol is not available to the public.
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
48
Results
Results date posted
| 2022 | Year | 02 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to submitting the paper
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053479
