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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041069
Receipt No. R000046868
Scientific Title Analysis on individual difference in pharmacokinetics of aprepitant and its metabolites, and investigation on predictive parameters of aprepitant response and adverse effects in Japanese patiens
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/10

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Basic information
Public title Analysis on individual difference in pharmacokinetics of aprepitant and its metabolites, and investigation on predictive parameters of aprepitant response and adverse effects in Japanese patiens
Acronym Analysis on individual difference in pharmacokinetics of aprepitant and its metabolites, and investigation on predictive parameters of aprepitant response and adverse effects in Japanese patiens
Scientific Title Analysis on individual difference in pharmacokinetics of aprepitant and its metabolites, and investigation on predictive parameters of aprepitant response and adverse effects in Japanese patiens
Scientific Title:Acronym Analysis on individual difference in pharmacokinetics of aprepitant and its metabolites, and investigation on predictive parameters of aprepitant response and adverse effects in Japanese patiens
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study evaluate the interindividual variabilities of plasma dispositions of aprepitant and its metabolites determined by LC-MS/MS and clinical responses and adverse effects by investigating the patient background, plasma concentrations of proteins related with aprepitant metabolism, and genetic variants of cytochrome P450.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma concentrations of aprepitant and its metabolites at 24 hours after the last oral administration of aprepitant.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients treated with aprepitant for chemotherapy induced nausea and vomiting
2. Patients receiving written informed consent
Key exclusion criteria 1. Patients discontinuing aprepitant
2. Patients who are judged by physicians as inappropriate for study enrollment
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code 4313192
Address 1-20-1 Handayama, Hamamatsu 431-3192
TEL 053-435-2763
Email pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Naito
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code 4313192
Address 1-20-1 Handayama, Hamamatsu 431-3192
TEL 053-435-2763
Homepage URL
Email pharmacyham-adm@umin.ac.jp

Sponsor
Institute Department of Hospital pharmacy
Amaterasu University School of Medicine
Institute
Department

Funding Source
Organization Department of Hospital pharmacy
Amaterasu University School of Medicine
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 Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Hamamatsu 431-3192
Tel 053-435-2111
Email rinri@hama-med.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
2020 Year 07 Month 13 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
2017 Year 08 Month 04 Day
Anticipated trial start date
2017 Year 08 Month 04 Day
Last follow-up date
2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Observational study
Object recruitment: All patients who visit our hospital and meet the selection criteria from August 2017 to July 2022
Primary outcome: Plasma concentrations of aprepitant and its metabolites at 24 hours after the last oral administration of aprepitant.
Antiemetic effects and adverse effects

Secondary outcome:
1. Plasma 4beta-hydroxycholesterol
2. Plasma miRNA-27b
3. Plasma 25-hydroxy vitamin D
4. Polymorphisms of CYP3A4 and CYP3A5
5. Blood inflammation marker levels
6. Concomitant regimen, type of anticancer drug, and dosage
7. Hyperglycemia-related markers (1,5-AG, C-peptide, glycoalbumin etc.)
8. Patient background data(sex, age, weight etc.)
9. Laboratory values
10. Concomitant drugs

Management information
Registered date
2020 Year 07 Month 10 Day
Last modified on
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046868

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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