UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030621 |
|---|---|
| Receipt number | R000034907 |
| Scientific Title | A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers |
| Date of disclosure of the study information | 2018/01/13 |
| Last modified on | 2018/12/28 10:39:56 |
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Basic information
Public title
A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers
Acronym
A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers
Scientific Title
A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers
Scientific Title:Acronym
A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers
Region
| Japan |
Condition
Condition
Japanese healthy adult male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of SJP-0139 and its metabolites in a single or twice daily oral administration of 800 mg SJP-0139 in healthy adult male volunteers
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Unchanged SJP-0139 and its metabolites in plasma and pharmacokinetic parameters over 8 days (single-dose) or 21 days (multiple-dose) after the last administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single-dose part: 800 mg SJP-0139 is orally administered.
Multiple-dose part: 800 mg SJP-0139 is orally administered twice-daily from Day 1 to Day 13 and once in the morning on Day 14.
Interventions/Control_2
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
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
1. Subjects who were capable of giving informed consent at the time of providing consent
2. Japanese healthy male adult volunteers aged between 20 to 55 (at the time of consent) who provided the written informed consent
3. Subjects who are able and willing to adhere the study instructions to the subjects defined in the protocol and the study schedule
Key exclusion criteria
1. Subjects with disease, medical history, physical findings, or laboratory abnormalities affecting evaluation of the study
2. Subjects with a medical history of allergies to drugs or food
3. Subjects with a Body mass index of less than 18.5 or exceeding 25.0 or with a weight of less than 50 kg
4. Subject who had underwent surgery known to affect gastrointestinal absorption of the drug (other than appendectomy and herniation)
5. Subjects with previous medical history or current signs of heart disease
6. Subjects who had participated in other clinical studies and had been dosed with other study drugs within 84 days preceding providing consent
7. Subjects who had used drugs other than the study drug used in this study within 7 days preceding treatment initiation of the study drug
8. Subjects who had taken grapefruit, grapefruit juice, or processed food containing those fruits within 7 days preceding treatment initiation of the study drug
9. Subjects who had taken dietary supplement products containing St. John's Wort within 14 days preceding treatment initiation of the study drug
10. (Only for multiple-dose part) Subjects who had shown any abnormal finding at ophthalmic examinations or who had severe myopia.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Ishigami |
Organization
Ishigami Clinic
Division name
Chief of Clinic
Zip code
Address
Nakanoshima Daibiru Building, 3-3-23, Nakanoshima, Kita-ku, Osaka
TEL
06-6131-4506
calci@yo.rim.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Sekiya |
Organization
Senju Pharmaceutical Co.,Ltd.
Division name
Clinical Development
Zip code
Address
2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan
TEL
06-6201-9605
Homepage URL
t-sekiya@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co.,Ltd.
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
Address
Tel
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
| 2018 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034907
