UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030621
Receipt number R000034907
Scientific Title A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers
Date of disclosure of the study information 2018/01/13
Last modified on 2018/12/28 10:39:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers

Acronym

A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers

Scientific Title

A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers

Scientific Title:Acronym

A phase I clinical pharmacology study of SJP-0139 with a single-dose and multiple-dose administration in healthy male volunteers

Region

Japan


Condition

Condition

Japanese healthy adult male volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the pharmacokinetics of SJP-0139 and its metabolites in a single or twice daily oral administration of 800 mg SJP-0139 in healthy adult male volunteers

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Unchanged SJP-0139 and its metabolites in plasma and pharmacokinetic parameters over 8 days (single-dose) or 21 days (multiple-dose) after the last administration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Single-dose part: 800 mg SJP-0139 is orally administered.

Multiple-dose part: 800 mg SJP-0139 is orally administered twice-daily from Day 1 to Day 13 and once in the morning on Day 14.

Interventions/Control_2


Interventions/Control_3


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

55 years-old >

Gender

Male

Key inclusion criteria

1. Subjects who were capable of giving informed consent at the time of providing consent
2. Japanese healthy male adult volunteers aged between 20 to 55 (at the time of consent) who provided the written informed consent
3. Subjects who are able and willing to adhere the study instructions to the subjects defined in the protocol and the study schedule

Key exclusion criteria

1. Subjects with disease, medical history, physical findings, or laboratory abnormalities affecting evaluation of the study
2. Subjects with a medical history of allergies to drugs or food
3. Subjects with a Body mass index of less than 18.5 or exceeding 25.0 or with a weight of less than 50 kg
4. Subject who had underwent surgery known to affect gastrointestinal absorption of the drug (other than appendectomy and herniation)
5. Subjects with previous medical history or current signs of heart disease
6. Subjects who had participated in other clinical studies and had been dosed with other study drugs within 84 days preceding providing consent
7. Subjects who had used drugs other than the study drug used in this study within 7 days preceding treatment initiation of the study drug
8. Subjects who had taken grapefruit, grapefruit juice, or processed food containing those fruits within 7 days preceding treatment initiation of the study drug
9. Subjects who had taken dietary supplement products containing St. John's Wort within 14 days preceding treatment initiation of the study drug
10. (Only for multiple-dose part) Subjects who had shown any abnormal finding at ophthalmic examinations or who had severe myopia.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Ishigami

Organization

Ishigami Clinic

Division name

Chief of Clinic

Zip code


Address

Nakanoshima Daibiru Building, 3-3-23, Nakanoshima, Kita-ku, Osaka

TEL

06-6131-4506

Email

calci@yo.rim.or.jp


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


Email

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


Email



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

2018 Year 01 Month 13 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 12 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 13 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 12 Month 28 Day

Last modified on

2018 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name