UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030621
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email t-sekiya@senju.co.jp

Sponsor
Institute Senju Pharmaceutical Co.,Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.