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Corrected QT (QTc) Study With Flucticasone Furoate and GW642444

NCT01209026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-06-08

No results posted yet for this study

Summary

A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in healthy male and female subjects. Key assessments will include 12- lead electrocardiogram (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.

Conditions

Interventions

DRUG

Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination

Novel dry powder inhaler

DRUG

Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination

Novel dry powder inhaler

DRUG

Placebo Inhaler

Matching placebo Novel dry powder inhaler. Lactose monohydrate and magnesium stearate.

DRUG

Moxifloxacin 400mg

Film coated oral tablet

DRUG

Moxifloxacin placebo

Film coated oral tablet

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-23
Primary Completion
2011-01-04
Completion
2011-01-04

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209026 on ClinicalTrials.gov