UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029704 |
|---|---|
| Receipt number | R000033938 |
| Scientific Title | Histamine H1 receptor occupancy of amino group-containing non-sedating antihistamines measured by PET in healthy male volunteers |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2018/11/21 10:23:00 |
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Basic information
Public title
Histamine H1 receptor occupancy of amino group-containing non-sedating antihistamines measured by PET in healthy male volunteers
Acronym
Histamine H1 receptor occupancy of non-sedating antihistamines
Scientific Title
Histamine H1 receptor occupancy of amino group-containing non-sedating antihistamines measured by PET in healthy male volunteers
Scientific Title:Acronym
Histamine H1 receptor occupancy of non-sedating antihistamines
Region
| Japan |
Condition
Condition
healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Histamine H1 receptor (H1R) antagonists often have sedative side
effects, which are caused by the blockade of the neural transmission of the
histaminergic neurons. We examine the brain H1R occupancy (H1RO) and
the subjective sleepiness of desloratadine, a new non-sedating antihistamine containing amino acid group,
comparing loratadine, another non-sedating antihistamine, as a negative active control.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Histamine H1 receptor occupancy of desloratadine 5 mg and loratadine 10 mg at Tmax after single oral administration
Key secondary outcomes
Correlation between histamine H1 receptor occupancy and subjective sleepiness and plasma pharmakokinetics after single oral administration of desloratadine 5 mg and loratadine 10 mg.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Positron emission tomography (PET) imaging with [11C]doxepin, a PET tracer that specifically binds to H1Rs, in healthy male volunteers after a single oral administration of placebo in a double-blind crossover study.
Interventions/Control_2
Positron emission tomography (PET) imaging with [11C]doxepin, a PET tracer that specifically binds to H1Rs, in healthy male volunteers after a single oral administration of desloratadine (5 mg) in a double-blind crossover study.
Interventions/Control_3
Positron emission tomography (PET) imaging with [11C]doxepin, a PET tracer that specifically binds to H1Rs, in healthy male volunteers after a single oral administration of loratadine (10 mg) in a double-blind crossover study.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy normal male subjects examined by health check using blood and brain MRI examination before PET scan
Key exclusion criteria
Healthy normal male subjects taking any drugs
Healthy normal male subjects who became another volunteers of PET studies.
Healthy normal male subjects with severe allergic diseases
Healthy normal male subjects with family history of glaucoma and benign prostatic hypertrophy
Healthy normal male subjects who can not take antihistamines and anticholinergic drugs.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Yanai |
Organization
Tohoku University Graduate School of Medicine
Division name
Pharmacology
Zip code
Address
Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan
TEL
022-717-8055
yanai@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Tashiro |
Organization
Tohoku University, Cyclotron and Radioisotope Center
Division name
Division of Cyclotron Nuclear Medicine
Zip code
Address
6-3, Aoba, Aramaki, Aoba-ku, Sendai, 980-8578, Japan
TEL
022-795-7802
Homepage URL
mtashiro@m.tohoku.ac.jp
Sponsor or person
Institute
Department of Pharmacology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medical Affairs
Clinical Development Center
Kyorin Pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学大学院医学系研究科・機能薬理学
東北大学サイクロトロン・ラジオアイソトープセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033938
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