UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029001 |
|---|---|
| Receipt number | R000032945 |
| Scientific Title | A phase I clinical pharmacology study of SJP-0135 |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2018/03/07 10:05:28 |
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Basic information
Public title
A phase I clinical pharmacology study of SJP-0135
Acronym
A phase I clinical pharmacology study of SJP-0135
Scientific Title
A phase I clinical pharmacology study of SJP-0135
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Makoto Araie |
Organization
Kanto Central Hospital
Division name
-
Zip code
Address
6-25-1, Kamiyoga, Setagaya-ku, Tokyo, 158-8531 Japan
TEL
03-3429-1171
araie-tky@umin.net
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
| 2017 | Year | 10 | Month | 01 | 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 | 07 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032945
