Histamine H1 receptor occupancy of amino group-containing non-sedating antihistamines measured by PET in healthy male volunteers

Phase 1

• Conditions: healthy male volunteers

• Registration Number: JPRN-UMIN000029704
• Lead Sponsor: Department of Pharmacology, Tohoku University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-07
• Study Completion: 2018-10-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histamine H1 receptor occupancy of desloratadine 5 mg and loratadine 10 mg at Tmax after single oral administration

Secondary Outcome Measures

Name	Time	Method
Correlation between histamine H1 receptor occupancy and subjective sleepiness and plasma pharmakokinetics after single oral administration of desloratadine 5 mg and loratadine 10 mg.