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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014009
Receipt No. R000016317
Scientific Title A phase 1 clinical pharmacological study with repeated oral doses of KAG-308
Date of disclosure of the study information 2014/05/20
Last modified on 2014/10/14

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Basic information
Public title A phase 1 clinical pharmacological study with repeated oral doses of KAG-308
Acronym A phase 1 clinical pharmacological study of KAG-308
Scientific Title A phase 1 clinical pharmacological study with repeated oral doses 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 repeated oral doses (after meals, twice a day, for 5 days) of KAG-308 in healthy adult male subjects.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 pharmacokinetic parameters
2. Urinary concentration of KAG-308 and the metabolites, and the excretion rate
3. Search for plasma unknown metabolites
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 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 KAG-308 40 ug
Interventions/Control_2 KAG-308 80 ug
Interventions/Control_3 KAG-308 160 ug
Interventions/Control_4 Placebo
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
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 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.
13. The subject who participated in the clinical trial of KAG-308 in the past, and take a dose of study drug.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Takahashi
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
Email TAKAHASHI_AKIRA@kaken.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaken Pharmaceutical Co., LTD
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 KAMIYASHIKI_TSUTOMU@kaken.co.jp

Sponsor
Institute Kaken Pharmaceutical Co., LTD
Institute
Department

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
2014 Year 05 Month 20 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
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 22 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
2014 Year 05 Month 20 Day
Last modified on
2014 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016317

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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