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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010941
Receipt No. R000012807
Scientific Title Pharmacokinetics(PK) study of meropenem in Epithelial Lining Fluid (ELF), an open-label study
Date of disclosure of the study information 2013/06/15
Last modified on 2019/07/06

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Basic information
Public title Pharmacokinetics(PK) study of meropenem in Epithelial Lining Fluid (ELF), an open-label study
Acronym PK study of meropenem in ELF
Scientific Title Pharmacokinetics(PK) study of meropenem in Epithelial Lining Fluid (ELF), an open-label study
Scientific Title:Acronym PK study of meropenem in ELF
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate PK and lung translatability of meropenem in ELF by Bronchoscopic Micro-sampling(BMS) analysis on healthy volunteers.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate PK in plasma and ELF of meropenem, the ratio ELF:plasma of meropenem
Key secondary outcomes To evaluate inflammatory cytokines (IL-1, IL-2, IL-6, IL-10, pro-calcitonine, etc) in serum after BMS.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Infusing meropenem 1g in an hour.
Interventions/Control_2 Infusing meropenem 2g in an hour
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteers except exclusion criteria and abnormalities proved by the pre-medical test. With informed consent as volunteers.
Key exclusion criteria 1) History of hypersensitivity caused by lidocaine hydrochloride.
2) History of hypersensitivity caused by carbapenem.
3) In medication.
4) Creatinine clearance <=30mL/min.
5) Smorker.
6) Hepatic or Renal disorder, Anemia proved by the pre-medical test.
7)Any other participants whose condition is inappropriate for the evaluation of this clinical study, judged by the investigator.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hasegawa
Organization Keio University, School of Medicine
Division name Center for Infectious diseases and Infection Control
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL 03-5363-3710
Email n-hasegawa@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Funatsu
Organization Keio University, School of Medicine
Division name Department of Medicine, Division of Pulmonary medicine
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL 03-5363-3793
Homepage URL
Email dodeko81@ybb.ne.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization DAINIPPON SUMITOMO PHARMA
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 15 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 30 Day
Date of IRB
2013 Year 05 Month 30 Day
Anticipated trial start date
2013 Year 06 Month 23 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 12 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012807

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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