UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046556 |
|---|---|
| Receipt number | R000052835 |
| Scientific Title | Optimal individual administration of linezolid and tedizolid using saliva concentrations to avoid blood sampling A single oral and intravenous dose of linezolid and tedizolid in healthy adult males (investigator-initiated clinical study) |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/01/08 21:29:16 |
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Basic information
Public title
Optimal individual administration of linezolid and tedizolid using saliva concentrations to avoid blood sampling
A single oral and intravenous dose of linezolid and tedizolid in healthy adult males (investigator-initiated clinical study)
Acronym
Optimal individual administration of linezolid and tedizolid using saliva concentrations to avoid blood sampling
A single oral and intravenous dose of linezolid and tedizolid in healthy adult males (investigator-initiated clinical study)
Scientific Title
Optimal individual administration of linezolid and tedizolid using saliva concentrations to avoid blood sampling
A single oral and intravenous dose of linezolid and tedizolid in healthy adult males (investigator-initiated clinical study)
Scientific Title:Acronym
Optimal individual administration of linezolid and tedizolid using saliva concentrations to avoid blood sampling
A single oral and intravenous dose of linezolid and tedizolid in healthy adult males (investigator-initiated clinical study)
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct the new non-invasive salivary therapeutic drug monitoring (TDM)
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total and unbound LZD concentrations in saliva or serum up to 10 hours after oral or intravenous LZD administration
Total and unbound TZD concentrations in saliva or serum up to 10 hours after oral or intravenous TZD 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 | Behavior,custom |
Interventions/Control_1
Six healthy male subjects receive LZD 600 mg or TZD 200 mg intravenously and orally after 1 week. Pharmacokinetic saliva and blood sampling were performed for 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after the oral and intravenous administration.
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
Key inclusion criteria
1) Healthy adult males
2) aged 20-50 years
3) BMI 18.5 kg/m2 or larger but less than 30.0 kg/m2
4) Provide informed consent
Key exclusion criteria
1) History of drug allergy
2) Hypersensitivity to the investigational drug
3) Participated in other clinical trials within the previous 2 weeks
4) Received drugs or supplements within the previous 3 days
5) Whole blood donor of 200 mL within the previous one month, blood component (platelets and plasma) donor within the previous 2 weeks, or Whole blood donor of 300 mL within the previous 3 months
6)
7) With childbearing potential and rejecting contraceptive methods during 1 week from the initial administration of the investigational drug
8) With abnormal findings on the medical examination within six months
9) Salivary gland disorder or oral disease
10) Liver or renal disease
11) Deemed inappropriate (for miscellaneous reasons) based on the assessment of either the principal investigator or the sub-investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Toyama University Graduate School of Medicine and Pharmaceutical Sciences
Division name
Department of Clinical Infectious Diseases
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-2281
yamamoto@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasuji |
Organization
Toyama University Graduate School of Medicine and Pharmaceutical Sciences
Division name
Department of Clinical Infectious Diseases
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-2281
Homepage URL
kawasuji@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama
Tel
076-415-8857
rinri@adm.u-toyama.ac.jp
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
| 2022 | 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
| 2020 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052835
