UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Histamine H1 receptor occupancy of amino group-containing non-sedating antihistamines measured by PET in healthy male volunteers
Title of the study (Brief title)	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	Kazuhiko Yanai
Organization	Tohoku University Graduate School of Medicine
Division name	Pharmacology
Address	Seiryo-machi 2-1, Aoba-Ku, Sendai 980-8575, Japan
TEL	022-717-8055
Email	yanai@med.tohoku.ac.jp

Public contact
Name of contact person	Manabu Tashiro
Organization	Tohoku University, Cyclotron and Radioisotope Center
Division name	Division of Cyclotron Nuclear Medicine
Address	6-3, Aoba, Aramaki, Aoba-ku, Sendai, 980-8578, Japan
TEL	022-795-7802
Homepage URL
Email	mtashiro@m.tohoku.ac.jp

Sponsor
Institute	Department of Pharmacology, Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033938