UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011878
Receipt number R000013883
Scientific Title A phase 1 clinical pharmacological study with a single oral dose of KAG-308
Date of disclosure of the study information 2013/09/27
Last modified on 2014/03/27 15:33:59

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Basic information

Public title

A phase 1 clinical pharmacological study with a single oral dose of KAG-308

Acronym

A phase 1 clinical pharmacological study of KAG-308

Scientific Title

A phase 1 clinical pharmacological study with a single oral dose of KAG-308

Scientific Title:Acronym

A phase 1 clinical pharmacological study of KAG-308

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and pharmacokinetics of a single oral dose of KAG-308 in healthy adult male subjects.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety
1. Body weight
2. Vital sign
3. Clinical test
4. Electrocardiogram
5. Adverse event

Pharmacokinetics
1. Changes over time in plasma concentration of KAG-308 and the metabolites, and pharmacokinetic parameters
2. Urinary and fecal concentration of KAG-308 and the metabolites, and the excretion rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

7

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

KAG-308 10 ug

Interventions/Control_2

KAG-308 20 ug

Interventions/Control_3

KAG-308 40 ug

Interventions/Control_4

KAG-308 80 ug

Interventions/Control_5

KAG-308 160 ug

Interventions/Control_6

KAG-308 320 ug

Interventions/Control_7

Placebo

Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

45 years-old >

Gender

Male

Key inclusion criteria

1. Weight:50 kg or more
2. BMI:18.5 or more, and less than 25.0
3. Japanese

Key exclusion criteria

1. The subject with failure or medical history of central nervous system disease, cardiac disease, or failure of cardiovascular, respiratory, blood and hematopoietic function system, gastrointestinal system, liver and renal function, thyroid function, pituitary function, adrenal function, etc. And the subject concluded by principal investigator (or sub investigators) difficult to ensure safety during the study.
2. The subject who does not meet the criteria of "clinical laboratory test, vital sign, 12 lead electrocardiograms".
3. The subject who tested positive after either HIV test, HBV test, HCV test, syphilis test, or tuberculosis test.
4. The subject with medical history of gastrointestinal tract symptom or gastrointestinal tract resection that affects pharmacokinetics.
5. The subject who is using drug or receiving therapy.
6. The subject with drug allergy or medical history.
7. The subject who felt sick at the time of blood donation or blood collection.
8. The subject who had been taken blood (blood donation, etc.) of more than 400 mL 90 days before the starting day of administration of the study drug, or the subject with the annual volume of blood collection more than 1200 mL including this study.
9. The subject who cannot stop either drinking alcohol during hospitalization or smoking from the day before the date of admission until the day of discharge.
10. The subject who tested positive on a urine abusable drug test.
11. The subject who is administered other study drug within 112 days past (16 weeks) before the scheduled administration date of the study drug.
12. The stuff of the institution or employees of the sponsor.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Kumagai

Organization

Kitasato University East Hospital

Division name

Clinical Trial Center

Zip code


Address

2-1-1, Asamizodai, Minami-ku, Sagamihara, Kanagawa, Japan

TEL

042-748-9111

Email

kuma-guy@za2.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayuki Kinoshita

Organization

Kaken Pharmaceutical Co., LTD

Division name

Clinical Development Department

Zip code


Address

28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan

TEL

03-5977-5111

Homepage URL


Email

KINOSHITA_TAKAYUKI@kaken.co.jp


Sponsor or person

Institute

Kaken Pharmaceutical Co., LTD

Institute

Department

Personal name



Funding Source

Organization

Kaken 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

2013 Year 09 Month 27 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

2013 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 29 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

2013 Year 09 Month 26 Day

Last modified on

2014 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name