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

Phase 1

Completed

• Conditions: Rhinitis, Allergic, Seasonal
• Interventions: Drug: GSK835726; Drug: Placebo

• Registration Number: NCT00605852
• Lead Sponsor: GlaxoSmithKline

Brief 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

Study Timeline

• Study Start: 2007-10-29
• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-31
• Primary Completion: 2008-05-03
• Study Completion: 2008-05-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects receiving treatment in cohort I	GSK835726	Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
Subjects receiving treatment in cohort I	Placebo	Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
Subjects receiving GSK835726 in cohort II	GSK835726	Eligible subjects will receive repeat doses of GSK835726 once daily for 7 days.
Subjects receiving placebo in cohort II	Placebo	Eligible subjects will receive repeat doses of placebo once daily for 7 days.
Subjects receiving treatment in cohort III	GSK835726	Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
Subjects receiving treatment in cohort III	Placebo	Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.

Primary Outcome Measures

Name	Time	Method
ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.	during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts	over 24 hours after dosing in single and repeat dose cohorts

Secondary Outcome Measures

Name	Time	Method
Changes in histamine-induced wheal and flare measurements	over 24 hours after dosing
time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half life (t1/2) following single and repeat oral dosing.	over 24 hours after dosing
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)	over 24 hours after dosing
Derived pharmacokinetic parameters for GSK835726 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-¥)), maximum observed plasma drug concentration (Cmax),	over 24 hours after dosing

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom