UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Pharmacokinetics on Day 7

Key secondary outcomes

Study type

Interventional

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

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

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

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

Email

araie-tky@umin.net

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

Institute

Senju Pharmaceutical Co.,Ltd.

Institute

Department

Personal name

Organization

Senju Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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