Brain histamine H1 receptor occupancy of newly-marketed non-sedating antihistamines: PET measurement in normal volunteers

Phase 4

• Conditions: ormal volunteers

• Registration Number: JPRN-UMIN000007383
• Lead Sponsor: Tohoku University Graduate School of Medicine

Brief Summary

There was no significant difference between the mean brain histamine H1 receptor occupancy (H1RO) after levocetirizine administration and fexofenadine administration. Similarly, subjective sleepiness was not significantly different between the two antihistamines and placebo. Neither subjective sleepiness nor plasma concentrations was significantly correlated with the brain H1RO of the two antihistamines. At therapeutic dose, levocetirizine does not bind significantly to the brain H1Rs and does not induce significant sedation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-27
• Study Completion: 2013-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who take no medication including antihistamines at present. 2. Subjects who do not take any PET scans within the recent 2 years. 3. No serious allergy 4. No convulsion at past 5. No frequent medical addmission 6. No glaucoma and prostatic hypertrophy 7. Subjects who can not take any anticholinergic and antihistaminergic drugs from medical points of view. 8. No brain MRI abnormality 9. Inadequate subjects from the point of medical view of the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified