NCT00694993

Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy Male Subjects

A Double-blind, Placebo-controlled, Randomized Single Dose Escalation Study and a Double-blind, Placebo-controlled, Randomised Parallel Group 14-days Once Daily Repeat Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of an Intranasal H1/H3 Dual Antagonist Compound in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, placebo-controlled, randomized single dose escalation study and a double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual antagonist compound in healthy male subjects.

Detailed description

A double-blind, placebo-controlled, randomized single dose escalation study and a double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual antagonist compound in healthy male subjects.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	GSK1004723	GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
DRUG	Placebo	Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.

Timeline

• Start date: 2007-12-17
• Primary completion: 2008-05-26
• Completion: 2008-05-26
• First posted: 2008-06-11
• Last updated: 2017-08-10

Locations

1 site across 1 country: Germany