UMIN-CTR Clinical Trial

Public title

Randomized, placebo-controlled Phase I study of SJP-0008 in healthy adult volunteers (single and repeated dose study)

Acronym

Phase I study of SJP-0008 in healthy adult volunteers

Scientific Title

Randomized, placebo-controlled Phase I study of SJP-0008 in healthy adult volunteers (single and repeated dose study)

Scientific Title:Acronym

Phase I study of SJP-0008 in healthy adult volunteers

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	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

Zip code

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

Name of contact person

1st name
Middle name
Last name	Tetsuo Kida

Organization

Senju Pharmaceutical co.,ltd.

Division name

Regulatory Affairs & Medical Writing, Clinical Development

Zip code

Address

2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan

TEL

06-6201-9605

Homepage URL

Email

tkida@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

2015

Year

09

Month

24

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

2015

Year

09

Month

01

Day

Date of IRB

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

Other related information

Registered date

2015

Year

09

Month

24

Day

Last modified on

2016

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022088