NCT00605852

Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects

A Double-blind, Placebo-controlled, Randomized Cross-over Single Dose Escalation Study and a Double-blind, Placebo-controlled, Randomised Parallel Group 7-days Once Daily Repeat Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral H1/H3 Dual Antagonist Compound in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess the safety and tolerability of single, escalating oral doses and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects

Detailed description

A double-blind, placebo controlled, randomized cross-over single dose escalation study and a double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral H1/H3 dual antagonist compound in healthy male subjects

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	GSK835726	GSK835726 will be available in single dose and repeat dose formulations.
DRUG	Placebo	Placebo will be given to subjects.

Timeline

• Start date: 2007-10-29
• Primary completion: 2008-05-03
• Completion: 2008-05-03
• First posted: 2008-01-31
• Last updated: 2017-08-21

Locations

1 site across 1 country: United Kingdom