UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers
Title of the study (Brief title)	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	Yoshitaka Ishigami
Organization	Ishigami Clinic
Division name	Chief of Clinic
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	Takuro Sekiya
Organization	Senju Pharmaceutical Co.,Ltd.
Division name	Clinical Development
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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