Pulmonary Disease, Chronic ObstructivePhase 1NCT01521377
QTc Study GSK573719+GW642444
A Phase 1 study testing Moxifloxacin, GSK573719/Vilanterol 125/25mcg and GSK573719 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Moxifloxacin, GSK573719/Vilanterol 125/25mcg and GSK573719
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2011to 5 Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until after the Follow Up visit
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
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- Body weight ≥ 45 kg and BMI within the range 18 - 29.5 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- No significant abnormality on 12-lead ECG at screening, including the following specific requirements:
- Ventricular rate ≥ 40 beats per minute
- PR interval ≤ 210msec
- Q waves < 30msec (up to 50 ms permitted in lead III only)
- QRS interval to be ≥ 60msec and < 120msec
- The waveforms must enable the QT interval to be clearly defined
- QTcF interval must be < 450msec (machine or manual reading).
- A 24 hour Holter ECG at screening that demonstrates no clinically significant abnormalities or finding that could interfere with interpretation of the study results, when assessed by an appropriately trained and experienced reviewer
- Subjects who are able to use the Novel DPIsatisfactorily.
- Capable of giving written informed consent and a signed and dated written informed consent is obtained, which includes compliance with the requirements and restrictions listed in the consent form.
- Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
- Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked)).
- Available to complete the study.
Who cannot join
- History or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
- History of symptomatic arrhythmias.
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (BPM) at screening.
- History of tendon disease/disorder related to quinolone treatment.
- History of sensitivity to any of the study medications, including moxifloxacin, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. In particular, the subject has a known allergy or hypersensitivity to quinolones, ipratropium bromide, tiotropium, atropine and any of its derivatives. Or any adverse reaction including immediate or delayed hypersensitivity to any β2 agonist or sympathomimetic drug,
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- Severe Milk Protein allergy
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as:
- an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125ml) of wine or 1 (25 ml) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Consumption of seville oranges, pummelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 3 month period.
- Pregnant females as determined by positive serum β-HCG test at screening or serum/ urine β-HCG prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Urinary cotinine levels indicative of smoking or history or regular use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled, Incomplete Block, Four Period Crossover , Repeat Dose Study to Evaluate the Effect of the Inhaled GSK573719/Vilanterol Combination and GSK573719 Monotherapy on Electrocardiographic Parameters, With Moxifloxacin as a Positive Control, in Healthy Subjects.
This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with placebo. At least 100 subjects will receive, four of five possible, 10-day repeat dose treatments. Treatments are placebo with a moxifloxacin placebo on day 10, placebo with moxifloxacin (400mg) on day 10, GSK573719/Vilanterol combination (125/25μg) with moxifloxacin placebo on day 10, GSK573719/Vilanterol combinatio (500/100μg) with moxifloxacin placebo on day 10, or GSK573719 (500μg) with a moxifloxacin placebo on day 10. All treatments are double blind except for moxifloxacin (400mg) and moxifloxacin placebo controls, given as a single-blind single dose on Day 10 of the appropriate treatment period.
Primary endpoints are individual time-matched changes from baseline QTcF for GSK573719/Vilanterol combination (125/25μg) and GSK573719 (500μg), 0-24 hours after dosing on Day 10. Secondary endpoints will include individual time-matched changes from baseline in QTcF for GSK573719/Vilanterol combination (500/100μg) and moxifloxacin (400mcg) 0-24 hours after dosing on Day 10. Also changes from baseline in QTci, QTcB, QT, QRS, RR, PR and ventricular rate at each time point after 10 days dosing of each GSK573719 and GSK573719/Vilanterol treatment and single dose moxifloxacin (400mg). Maximal change from baseline 0-24hours after dosing on day 10 will be derived for QTcF, QTci and QTcB for each treatment. Plasma concentrations on Day 10 (0-24 hours) and pharmacokinetic parameters of GSK573719 and Vilanterol will also be derived. Key assessments: 12- lead electrocardiogram (ECG), pharmacokinetics. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events (AEs).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo Moxifloxacin, Moxifloxacin, GSK573719/Vilanterol 125/25mcg, GSK573719, GSK573719/Vilanterol 500/100mcg
- Keywords
- LAMA, Respiratory, COPD, Tolerability, Beta-2 Agonist, Safety, Pharmacokinetics, Pharmacodynamics, LABA, Muscarinic Receptor Agonist, Healthy subjects, Moxifloxacin, Anticholinergic, GW642444, GSK573719, QTc
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo MoxifloxacinDrug
Single dose placebo oral tablet Moxifloxacin
MoxifloxacinDrug
Single oral dose tablet Moxifloxacin (400mg)
GSK573719/Vilanterol 125/25mcgDrug
Single inhalation from GSK573719/Vilanterol 125/25mcg DPI once daily
GSK573719Drug
Single inhalation from GSK573719 500mcg DPI once daily
GSK573719/Vilanterol 500/100mcgDrug
Single inhalation from GSK573719/Vilanterol 500/100mcg DPI once daily
Placebo DPIDrug
Single Inhalation from matching Placebo DPI once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single inhalation from matching placebo dry powder inhaler once daily on days 1-10. Single dose placebo oral tablet moxifloxacin. Receives: Drug: Placebo Moxifloxacin; Drug: Placebo DPI |
| Moxifloxacin Positive | Active comparator | Single inhalation from matching placebo dry powder inhaler once daily on days 1-10. Single dose oral tablet moxifloxacin (400mg) on day 10. Receives: Drug: Moxifloxacin; Drug: Placebo DPI |
| GSK573719 Supra-therapeutic dose | Experimental | Single inhalation from GSK573719 (500 microgram) dry powder inhaler once daily on days 1-10. Single dose placebo oral moxifloxacin. Receives: Drug: Placebo Moxifloxacin; Drug: GSK573719 |
| GSK573719/Vilanterol Therapeutic dose | Experimental | Single inhalation from GSK573719/Vilanterol (125/25 microgram) dry powder inhaler once daily on days 1-10. Single dose placebo oral tablet moxifloxacin on day 10. Receives: Drug: Placebo Moxifloxacin; Drug: GSK573719/Vilanterol 125/25mcg |
| GSK573719/Vilanterol Supra-therapeutic dose | Experimental | Single inhalation from GSK573719/Vilanterol (500/100 microgram) dry powder inhaler once daily on days 1-10. Single dose placebo oral tablet moxifloxacin on day 10. Receives: Drug: Placebo Moxifloxacin; Drug: GSK573719/Vilanterol 500/100mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF Interval with GSK573719/ Vilanterol 125/25mcg
To estimate the effect of GSK573719/ Vilanterol 125/25mcg on the QTcF interval as compared with placebo after 10 days dosing.
Measured: Screening, Day 1, and Day 10
Change from baseline in QTcF Interval with GSK573719 500 mcg
To estimate the effect of GSK573719 500 mcg (four times the highest combination dose being evaluated in Phase III trials) on the QTcF interval as compared with placebo after 10 days dosing.
Measured: Screening, Day 1, and Day 10
Secondary outcomes (8)
Change from baseline in QTcF interval with GSK573719/Vilanterol 500/100mcg
To estimate the effect of GSK573719/ Vilanterol 500/100mcg (four times the highest combination dose being evaluated in Phase III trials) on the QTcF interval as compared with placebo after 10 days dosing.
Measured: Screening, Day 1, and Day 10
Change from baseline in QTci and QTcB interval for GSK573719/Vilanterol 125/25mcg and 500/100mcg as compared with timematched placebo.
To estimate the effect of GSK573719/Vilanterol 125/25mcg and 500/100mcg on the QTci and QTcB interval interval as compared with placebo after 10 days dosing.
Measured: Screening, Day 1, and Day 10
Change from baseline in QTci and QTcB interval for GSK573719 500mcg as compared with time-matched placebo.
To estimate the effect of GSK573719 500mcg, on the QTci and QTcB interval interval as compared with placebo after 10 days dosing.
Measured: Screening, Day 1, and Day 10
Change from baseline in QTcF interval for moxifloxacin as compared with time-matched placebo.
To estimate the effect of a single oral dose of 400mg moxifloxacin on the QTcF interval as compared with placebo on day 10.
Measured: Screening, Day 1, and Day 10
Change from baseline in QTci and QTcB interval for moxifloxacin as compared with time-matched placebo.
To estimate the effect of a single oral dose of 400mg moxifloxacin on the QTci and QTcB interval interval as compared with placebo on day 10.
Measured: Screening, Day 1, and Day 10
Change from baseline at each timepoint on Day 10 for other cardiac electrophysiological parameters: QT, QRS, RR, PR and ventricular rate for each active treatment compared with placebo.
To estimate the effect of all active treatments on other cardiac electrophysiological parameters as compared with placebo after 10 days dosing.
Measured: Screening, Day 1, and Day 10
Plasma concentrations of GSK573719 and Vilanterol and derived pharmacokinetic parameters including Cmax, tmax and AUC(0-τ).
To characterise the pharmacokinetic profiles of GSK573719 and Vilanterol when administered in combination via novel DPI.
Measured: Screening, Day 1, and Day 10
Plasma concentrations of GSK573719 and derived pharmacokinetic parameters including Cmax, tmax and AUC(0-τ).
To characterise the pharmacokinetic profile of supra-therapeutic dose of GSK573719 when administered as monotherapy via novel DPI.
Measured: Screening, Day 1, and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study start19 Dec 2011
- Primary completion5 Jun 2012
- Study completion5 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521377
- Sponsor's protocol ID
- 114635
- Status last verified
- Jun 2017
- First submitted
- 26 Jan 2012
- Last updated
- 12 Jun 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Incomplete Block, Four Period Crossover , Repeat Dose Study to Evaluate the Effect of the Inhaled GSK573719/Vilanterol Combination and GSK573719 Monotherapy on Electrocardiographic Parameters, With Moxifloxacin as a Positive Control, in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01521377
- Acronym / sponsor ID
- 114635
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- LAMA, Respiratory, COPD, Tolerability, Beta-2 Agonist, Safety, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2011 (actual)
- Primary completion
- 5 Jun 2012 (actual)
- Study completion
- 5 Jun 2012 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with placebo. At least 100 subjects will receive, four of five possible, 10-day repeat dose treatments. Treatments are placebo with a moxifloxacin placebo on day 10, placebo with moxifloxacin (400mg) on day 10, GSK573719/Vilanterol combination (125/25μg) with moxifloxacin placebo on day 10, GSK573719/Vilanterol combinatio (500/100μg) with moxifloxacin placebo on day 10, or GSK573719 (500μg) with a moxifloxacin placebo on day 10. All treatments are double blind except for moxifloxacin (400mg) and moxifloxacin placebo controls, given as a single-blind single dose on Day 10 of the appropriate treatment period.
Primary endpoints are individual time-matched changes from baseline QTcF for GSK573719/Vilanterol combination (125/25μg) and GSK573719 (500μg), 0-24 hours after dosing on Day 10. Secondary endpoints will include individual time-matched changes from baseline in QTcF for GSK573719/Vilanterol combination (500/100μg) and moxifloxacin (400mcg) 0-24 hours after dosing on Day 10. Also changes from baseline in QTci, QTcB, QT, QRS, RR, PR and ventricular rate at each time point after 10 days dosing of each GSK573719 and GSK573719/Vilanterol treatment and single dose moxifloxacin (400mg). Maximal change from baseline 0-24hours after dosing on day 10 will be derived for QTcF, QTci and QTcB for each treatment. Plasma concentrations on Day 10 (0-24 hours) and pharmacokinetic parameters of GSK573719 and Vilanterol will also be derived. Key assessments: 12- lead electrocardiogram (ECG), pharmacokinetics. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Moxifloxacin, Drug: Placebo DPISingle inhalation from matching placebo dry powder inhaler once daily on days 1-10. Single dose placebo oral tablet moxifloxacin. |
| Moxifloxacin Positive | Active comparator | Drug: Moxifloxacin, Drug: Placebo DPISingle inhalation from matching placebo dry powder inhaler once daily on days 1-10. Single dose oral tablet moxifloxacin (400mg) on day 10. |
| GSK573719 Supra-therapeutic dose | Experimental | Drug: Placebo Moxifloxacin, Drug: GSK573719Single inhalation from GSK573719 (500 microgram) dry powder inhaler once daily on days 1-10. Single dose placebo oral moxifloxacin. |
| GSK573719/Vilanterol Therapeutic dose | Experimental | Drug: Placebo Moxifloxacin, Drug: GSK573719/Vilanterol 125/25mcgSingle inhalation from GSK573719/Vilanterol (125/25 microgram) dry powder inhaler once daily on days 1-10. Single dose placebo oral tablet moxifloxacin on day 10. |
| GSK573719/Vilanterol Supra-therapeutic dose | Experimental | Drug: Placebo Moxifloxacin, Drug: GSK573719/Vilanterol 500/100mcgSingle inhalation from GSK573719/Vilanterol (500/100 microgram) dry powder inhaler once daily on days 1-10. Single dose placebo oral tablet moxifloxacin on day 10. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- A female subject is eligible to participate if she is of:
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Body weight ≥ 45 kg and BMI within the range 18 - 29.5 kg/m2 (inclusive).
Key exclusion criteria (23 listed)
- History or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
- History of symptomatic arrhythmias.
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (BPM) at screening.
- History of tendon disease/disorder related to quinolone treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo MoxifloxacinSingle dose placebo oral tablet Moxifloxacin | Drug | GSK573719 Supra-therapeutic dose, GSK573719/Vilanterol Supra-therapeutic dose, GSK573719/Vilanterol Therapeutic dose, Placebo |
| MoxifloxacinSingle oral dose tablet Moxifloxacin (400mg) | Drug | Moxifloxacin Positive |
| GSK573719/Vilanterol 125/25mcgSingle inhalation from GSK573719/Vilanterol 125/25mcg DPI once daily | Drug | GSK573719/Vilanterol Therapeutic dose |
| GSK573719Single inhalation from GSK573719 500mcg DPI once daily | Drug | GSK573719 Supra-therapeutic dose |
| GSK573719/Vilanterol 500/100mcgSingle inhalation from GSK573719/Vilanterol 500/100mcg DPI once daily | Drug | GSK573719/Vilanterol Supra-therapeutic dose |
| Placebo DPISingle Inhalation from matching Placebo DPI once daily | Drug | Moxifloxacin Positive, Placebo |
Primary outcome
Change from baseline in QTcF Interval with GSK573719/ Vilanterol 125/25mcg
Time frame: Screening, Day 1, and Day 10
To estimate the effect of GSK573719/ Vilanterol 125/25mcg on the QTcF interval as compared with placebo after 10 days dosing.
Change from baseline in QTcF Interval with GSK573719 500 mcg
Time frame: Screening, Day 1, and Day 10
To estimate the effect of GSK573719 500 mcg (four times the highest combination dose being evaluated in Phase III trials) on the QTcF interval as compared with placebo after 10 days dosing.
8 secondary outcomes
Change from baseline in QTcF interval with GSK573719/Vilanterol 500/100mcg
Time frame: Screening, Day 1, and Day 10
Change from baseline in QTci and QTcB interval for GSK573719/Vilanterol 125/25mcg and 500/100mcg as compared with timematched placebo.
Time frame: Screening, Day 1, and Day 10
Change from baseline in QTci and QTcB interval for GSK573719 500mcg as compared with time-matched placebo.
Time frame: Screening, Day 1, and Day 10
Change from baseline in QTcF interval for moxifloxacin as compared with time-matched placebo.
Time frame: Screening, Day 1, and Day 10
Change from baseline in QTci and QTcB interval for moxifloxacin as compared with time-matched placebo.
Time frame: Screening, Day 1, and Day 10
Change from baseline at each timepoint on Day 10 for other cardiac electrophysiological parameters: QT, QRS, RR, PR and ventricular rate for each active treatment compared with placebo.
Time frame: Screening, Day 1, and Day 10
Plasma concentrations of GSK573719 and Vilanterol and derived pharmacokinetic parameters including Cmax, tmax and AUC(0-τ).
Time frame: Screening, Day 1, and Day 10
Plasma concentrations of GSK573719 and derived pharmacokinetic parameters including Cmax, tmax and AUC(0-τ).
Time frame: Screening, Day 1, and Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Results for study 114635 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin, GSK573719/Vilanterol 125/25mcg and GSK573719 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in QTcF Interval with GSK573719/ Vilanterol 125/25mcg (time frame: Screening, Day 1, and Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.