UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized, placebo-controlled Phase I study of SJP-0008 in healthy adult volunteers (single and repeated dose study)
Title of the study (Brief title)	Phase I study of SJP-0008 in healthy adult volunteers
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the pharmacokinetics, safety and tolerability of single and repeated dose of SJP-0008 in healthy adult volunteers, and to evaluate the effect of meal intake on pharmacokinetics of SJP-0008.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety evaluation (Clinical examination, Vital sign, Ophthalmic examination, Laboratory test, Adverse event) and Pharmacokinetics of SJP-0008
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SJP-0008 is single orally administrated.
Interventions/Control_2	Placebo is single orally administrated.
Interventions/Control_3	SJP-0008 is single orally administrated both under fasting and fed conditions.
Interventions/Control_4	Placebo is single orally administrated both under fasting and fed conditions.
Interventions/Control_5	SJP-0008 is orally administrated by once a day for 7 days.
Interventions/Control_6	Placebo is orally administrated by once a day for 7 days.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Male
Key inclusion criteria	1) Signature of the subject on the Informed Consent Form. 2) Male subject who is from 20 to35 year of age.
Key exclusion criteria	1) History of serious disease (e.g.: eye, liver, kidney, cardiac, digestive or blood disease) 2) Subjects with cardiac disease including cardiac failure and ischemic heart disease. 3) Subjects with QTc interval of 450 ms or greater. 4) Subjects with notable respiratory arrhythmia, frequent premature beat or branch block. 5) Subjects with abnormal of serum electrolyte levels. 6) Subjects with eGFR of under 60 mL/min/1.73 m^2. 7) Subjects with exceed reference level of AST or ALT. 8) History of drug allergy. 9) Use of any drugs (including over the counter drugs) within past 2 week. 10) Subjects with donation of blood more than 400 mL within past 3 months. 11) Participation in any other clinical study within past 4 months. 12) History of keratorefractive surgery or traumatic injury of any eyes. 13) Willing to use contact lens during the study. 14) Subject with best-corrected visual acuity equal to or less than 1.0. 15) Subject with BMI less than 18.5 or more than 25.0. 16) Subjects do not agree with contraception or correspondence to partner's pregnancy.
Target sample size	90

Research contact person
Name of lead principal investigator	1) Toru Nakazawa, 2) Osamu Matsuoka
Organization	1) Tohoku University Graduate School of Medicine 2) Medical Corporation Heishinkai, ToCROM Clinic
Division name	1) Department of Ophthalmology, 2) NA
Address	1) 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan, 2) 6-26-8 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
TEL	022-717-7294
Email	ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Tetsuo Kida
Organization	Senju Pharmaceutical co.,ltd.
Division name	Regulatory Affairs & Medical Writing, Clinical Development
Address	2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan
TEL	06-6201-9605
Homepage URL
Email	tkida@senju.co.jp

Sponsor
Institute	Senju Pharmaceutical co.,ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2015 Year 09 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 24 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	2015 Year 09 Month 24 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022088