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
Overview
- Phase
- Phase 1
- Intervention
- GSK835726
- Conditions
- Rhinitis, Allergic, Seasonal
- Sponsor
- GlaxoSmithKline
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Subjects receiving treatment in cohort I
Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
Intervention: GSK835726
Subjects receiving treatment in cohort I
Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
Intervention: Placebo
Subjects receiving GSK835726 in cohort II
Eligible subjects will receive repeat doses of GSK835726 once daily for 7 days.
Intervention: GSK835726
Subjects receiving placebo in cohort II
Eligible subjects will receive repeat doses of placebo once daily for 7 days.
Intervention: Placebo
Subjects receiving treatment in cohort III
Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
Intervention: GSK835726
Subjects receiving treatment in cohort III
Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
Intervention: Placebo
Outcomes
Primary Outcomes
ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
Time Frame: 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
Time Frame: over 24 hours after dosing in single and repeat dose cohorts
Secondary Outcomes
- 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)
- Changes in histamine-induced wheal and flare measurements(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)