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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009858
Receipt No. R000011550
Scientific Title A multicenter, open-label, single-dose study to investigate the effects of the ABCC4 (MRP4) rs3765534 G>A polymorphism on the pharmacokinetics of ceftizoxime in East Asian population
Date of disclosure of the study information 2013/02/01
Last modified on 2014/08/26

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Basic information
Public title A multicenter, open-label, single-dose study to investigate the effects of the ABCC4 (MRP4) rs3765534 G>A polymorphism on the pharmacokinetics of ceftizoxime in East Asian population
Acronym The effects of the ABCC4 (MRP4) rs3765534 G>A polymorphism on the pharmacokinetics of ceftizoxime in East Asian population
Scientific Title A multicenter, open-label, single-dose study to investigate the effects of the ABCC4 (MRP4) rs3765534 G>A polymorphism on the pharmacokinetics of ceftizoxime in East Asian population
Scientific Title:Acronym The effects of the ABCC4 (MRP4) rs3765534 G>A polymorphism on the pharmacokinetics of ceftizoxime in East Asian population
Region
Japan Asia(except Japan)

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1)To determine whether the ABCC4 (MRP4) rs3765534 G>A polymorphism affects the pharmacokinetics of cefozolin in humans.
2)To investigate whether ethnicity (Chinese, Korean or Japanese) affects the pharmacokinetics of ceftizoxime.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetic parameters of ceftizoxime:
-Cmax: maximum measured serum concentration over the time span specified
-AUClast: the area under the serum concentration versus time curve, from time 0 to the last measurable concentration
-AUCinf: the area under the serum concentration versus time curve from time 0 to infinity
-t1/2: the time necessary for the serum concentration of drug to decrease by half
-Vd: the total volume of distribution
-CLtot: the total body clearance
-CLren: the renal clearance
Key secondary outcomes Adverse events

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 A single intravenous dose of ceftizoxime sodium 0.5 g administered over 30 min
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1)Healthy male and female volunteers, age ranged 20 to 50 years (both inclusive)
2)A subject with body weight between 45 kg (inclusive) and 80 kg (inclusive) for female, and between 50 kg (inclusive) and 90 kg (inclusive) for male, and body mass index (BMI) between 17 (inclusive) and 28 (inclusivee) for both gender.
3)Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (including the case that the investigator considers the deviation to be irrelevant for the purpose of the study)
Key exclusion criteria 1)A subject with history of allergies including study drug or any other food and drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
2)A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, gastrointestinal, respiratory (including asthma and COPD), endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
3)A subject who shows a positive reaction to any one of serology tests (hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody).
4)A subject with a history of surgery (except simple appendectomy or repair of hernia)
5)A subject with history of drug abuse or positive urine drug screening test
6)A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.)
7)A subject who consumes more than 7 units of alcohol (140g) per week or unable to stop drinking throughout the study period
8)A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)
9)A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products
10)A female subject who are pregnant or breast feeding
11)A female subject who does not agree to use routinely adequate contraception* from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug despite having a childbearing potential and being sexually active with a non-sterilized male partner.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Ohashi
Organization Oita University Faculty of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL 097-586-5952
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Kotegawa
Organization Oita University Faculty of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL 097-586-5952
Homepage URL
Email kotet@oita-u.ac.jp

Sponsor
Institute Department of Clinical Pharmacology and Therapeutics,
Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Grant-in-aid from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 1)Clinical Pharmacolgy Research Center, Peking Union Medical College Hospital, China
2)Clinical Trials Center, Seoul National University Hospital, Korea
3)Center for Advanced Medical Innovation, Kyushu University, Fukuoka, Japan

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 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
2012 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2013 Year 12 Month 17 Day
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 02 Month 28 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 24 Day
Last modified on
2014 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011550

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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