UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I clinical pharmacology study of SJP-0135
Title of the study (Brief title)	A phase I clinical pharmacology study of SJP-0135
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the pharmacokinetics and safety of SJP-0135 compared to 0.1% brimonidine tartrate or 0.5% timolol ophthalmic solution administered one drop twice daily for 7 days to healthy subjects
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetics on Day 7
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One drop of SJP-0135 is instilled into each eye twice-daily (in the morning and in the evening) for 7 days.
Interventions/Control_2	One drop of 0.1% brimonidine tartrate ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 7 days.
Interventions/Control_3	One drop of 0.5% timolol ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 7 days.
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	35 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Written informed consent obtained after adequate explanation on participating the study 2) Japanese male or female aged 20 to 35 years at consent 3) Able and willing to adhere the study instructions to the subjects defined in the protocol and the study schedule 4) IOP >= 10 mmHg and =< 20 mmHg in each eye, and asymmetry of IOP not greater than 5 mmHg
Key exclusion criteria	1) Presence of any disease irrespective of receiving medical treatment 2) History of a serious systemic disease 3) History of a serious psychiatric disorder 4) History of bronchial asthma 5) History of ocular surgery or history of ocular injury considered to be inappropriate to participate in the study 6) History of drug allergy 7) Use of any drugs within 14 days prior to the start of the study treatment 8) Males or females who made blood donation of 400 mL or more within 84 days or 112 days, respectively, prior to the start of the study treatment 9) Participated in any other clinical trial within past 90 days and received any other investigational drug or plans to participate in any other clinical trial during the study 10) Presence of abnormal ophthalmologic findings 11) Anticipated wearing of any contact lenses 12) Best corrected acuity <1.0 13) Body mass index < 18.5 or >= 25.0 14) Females who are pregnant, breastfeeding, or potentially pregnant. Or females who desire to be pregnant or males whose partners desire to be pregnant, or males or females who do not intend to use a reliable means of contraception from consent to the end of the study 15) Prior ocular instillation of SJP-0135
Target sample size	30

Research contact person
Name of lead principal investigator	Makoto Araie
Organization	Kanto Central Hospital
Division name	-
Address	6-25-1, Kamiyoga, Setagaya-ku, Tokyo, 158-8531 Japan
TEL	03-3429-1171
Email	araie-tky@umin.net

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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 25 Day
Anticipated trial start date	2017 Year 10 Month 01 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 09 Month 05 Day
Last modified on	2018 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032945