AsthmaPhase 1NCT01721135
A Study to Evaluate the Effect of Two Different Repeat Doses of GSK2190915 on the QTc Interval.
A Phase 1 study testing GSK2190915 100mg, GSK2190915 200mg and moxifloxacin 400mg in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study is a randomized, placebo controlled, four way crossover, in which the the effect of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin 400mg (single dose) with a weeks washout… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- GSK2190915 100mg, GSK2190915 200mg and moxifloxacin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Dec 2014
- 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
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5x Upper limit of normal (ULN)
- Healthy as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- 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 . Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods. Those of child-bearing potential must agree to use one of the protocol contraception methods.
- Body mass index (BMI) within the range 18.5-29.0 kg/m2 (inclusive)
- Capable of giving written informed consent
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- Current non-smokers who have not used tobacco products in the 6 month period preceding screening
- No significant abnormality on 12-lead electrocardiogram (ECG) at screening
- A 24 hour Holter ECG at screening that demonstrates no clinically significant abnormalities
Who cannot join
- A physician deems the subject unsuitable for the study
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias
- A blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- History or presence of any medically significant disease, or any disorder. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
- A positive result for Hepatitis B or Hepatitis C within 3 months of screening
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- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- A positive pre-study drug/alcohol screen
- A positive test for Human Immunodeficiency Virus (HIV) antibody
- History of regular alcohol consumption within 6 months of the study
- The subject has participated in a clinical trial and has received an investigational product within 3 months of the first dosing day in the current study
- 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 from 14 days before screening until the follow-up visit unless permitted by the investigator
- History of sensitivity to any of the study medications
- 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
- Lactating females
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo Controlled, Four-way Cross-over Study to Assess Cardiac Re-polarisation Following Repeat Dosing With GSK2190915 and Placebo for Five Days, With Moxifloxacin as a Positive Control, in Healthy Male and Female Subjects.
This study is a randomized, placebo controlled, four way crossover, in which the the effect of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin 400mg (single dose) with a weeks washout prior to starting the next course. Key assessments include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events .
Read the detailed description
This is a randomized, placebo controlled, four way crossover thorough QT study to evaluate the effect of repeat dose GSK2190915 on the QTc interval in healthy male and female subjects. Approximately 48 subjects will receive oral placebo, GSK2190915 (100mg or 1000mg) and moxifloxacin (400mg). GSK2190915 or matching placebo will be given once daily for 5 days with a moxifloxacin matching placebo given on Day 5. Moxifloxacin (positive control) will be given as a single-blind single dose on Day 5 with placebo administered on Days 1-4. Individual time-matched changes from baseline in QTcF (difference from placebo) for GSK2190915 will be determined 0-24 hours after dosing on Day 5 (primary endpoint). Secondary endpoints will include changes from baseline in QTcF, QTcB and QT interval at each timepoint after 5 days dosing of GSK2190915 and single dose moxifloxacin (400mg). Plasma concentrations on Day 5 (0-24 hours) and pharmacokinetic parameters of GSK2190915 will also be derived.
- Conditions
- Asthma
- Being tested
- GSK2190915 100mg, GSK2190915 200mg, moxifloxacin 400mg, moxifloxacin placebo, GSK2190915 placebo
- Keywords
- moxifloxacin, GSK2190915, pharmacokinetics, QTc
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2190915 100mgDrug
Film coated oral tablet
GSK2190915 200mgDrug
Film coated oral tablet
moxifloxacin 400mgDrug
Film coated oral tablet
moxifloxacin placeboDrug
Film coated oral tablet
GSK2190915 placeboDrug
Film coated oral tablet
| Study group | Role | What they receive |
|---|---|---|
| GSK2190915 100mg | Experimental | GSK2190915 100mg on days 1-5; moxifloxacin placebo on day 5 Receives: Drug: GSK2190915 100mg; Drug: moxifloxacin placebo; Drug: GSK2190915 placebo |
| GSK2190915 1000mg | Experimental | GSK2190915 1000mg on days 1-5; moxifloxacin placebo on day 5 Receives: Drug: GSK2190915 200mg; Drug: moxifloxacin placebo |
| moxifloxacin 400mg | Active comparator | placebo tablet on days 1-5; moxifloxacin 400mg on day 5 Receives: Drug: moxifloxacin 400mg; Drug: GSK2190915 placebo |
| placebo | Placebo comparator | placebo tablet on days 1-5; moxifloxacin placebo on day 5 Receives: Drug: moxifloxacin placebo; Drug: GSK2190915 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 100mg GSK2190915 as compared with time-matched placebo
Measured: 5 days
Secondary outcomes (8)
Change from baseline in QTcF interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 1000mg GSK2190915 as compared with time-matched placebo
Measured: 5 days
Change from baseline in QTcB interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 100mg and 1000mg GSK2190915 as compared with time-matched placebo
Measured: 5 days
Change from baseline in QTcF interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for moxifloxacin as compared with time-matched placebo
Measured: 5 days
Plasma concentrations of GSK2190915 taken on Day 5 to derive pharmacokinetic parameters including Maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax) and Area under the concentration-time curve over the dosing interval (AUC(0-τ))
Measured: 5 days
Heart rate and ECG parameters taken on Day 1 and Day 5 compared with concentration of Plasma GSK2190915 to find relationship
Measured: 5 days
Maximal change from baseline on Day 5 for QTcF and QTcB
Measured: 5 days
Change from baseline at each timepoint on Day 5 for other cardiac electrophysiological parameters: QT, QRS, RR, PR and ventricular rate
Measured: 5 days
Assessment of safety and tolerability of GSK2190915 by 12-lead ECGs, vital signs, adverse events and clinical laboratory tests throughout treatment period
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Study was terminated due to toxicology findings after screening started but before first subject first dose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01721135
- Sponsor's protocol ID
- 112360
- Status last verified
- Aug 2013
- First submitted
- 1 Nov 2012
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled, Four-way Cross-over Study to Assess Cardiac Re-polarisation Following Repeat Dosing With GSK2190915 and Placebo for Five Days, With Moxifloxacin as a Positive Control, in Healthy Male and Female Subjects.
- ClinicalTrials.gov ID
- NCT01721135
- Acronym / sponsor ID
- 112360
- Conditions
- Asthma
- Keywords
- moxifloxacin, GSK2190915, pharmacokinetics, QTc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was terminated due to toxicology findings after screening started but before first subject first dose.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 5 Nov 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 study is a randomized, placebo controlled, four way crossover, in which the the effect of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin 400mg (single dose) with a weeks washout prior to starting the next course. Key assessments include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events .
Detailed description
This is a randomized, placebo controlled, four way crossover thorough QT study to evaluate the effect of repeat dose GSK2190915 on the QTc interval in healthy male and female subjects. Approximately 48 subjects will receive oral placebo, GSK2190915 (100mg or 1000mg) and moxifloxacin (400mg). GSK2190915 or matching placebo will be given once daily for 5 days with a moxifloxacin matching placebo given on Day 5. Moxifloxacin (positive control) will be given as a single-blind single dose on Day 5 with placebo administered on Days 1-4. Individual time-matched changes from baseline in QTcF (difference from placebo) for GSK2190915 will be determined 0-24 hours after dosing on Day 5 (primary endpoint). Secondary endpoints will include changes from baseline in QTcF, QTcB and QT interval at each timepoint after 5 days dosing of GSK2190915 and single dose moxifloxacin (400mg). Plasma concentrations on Day 5 (0-24 hours) and pharmacokinetic parameters of GSK2190915 will also be derived.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GSK2190915 100mg | Experimental | Drug: GSK2190915 100mg, Drug: moxifloxacin placebo, Drug: GSK2190915 placeboGSK2190915 100mg on days 1-5; moxifloxacin placebo on day 5 |
| GSK2190915 1000mg | Experimental | Drug: GSK2190915 200mg, Drug: moxifloxacin placeboGSK2190915 1000mg on days 1-5; moxifloxacin placebo on day 5 |
| moxifloxacin 400mg | Active comparator | Drug: moxifloxacin 400mg, Drug: GSK2190915 placeboplacebo tablet on days 1-5; moxifloxacin 400mg on day 5 |
| placebo | Placebo comparator | Drug: moxifloxacin placebo, Drug: GSK2190915 placeboplacebo tablet on days 1-5; moxifloxacin placebo on day 5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female between 18 and 65 years of age inclusive
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5x Upper limit of normal (ULN)
- Healthy as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- 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 . Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods. Those of child-bearing potential must agree to use one of the protocol contraception methods.
- Body mass index (BMI) within the range 18.5-29.0 kg/m2 (inclusive)
Key exclusion criteria (19 listed)
- A physician deems the subject unsuitable for the study
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias
- A blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- History or presence of any medically significant disease, or any disorder. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
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 |
|---|---|---|
| GSK2190915 100mgFilm coated oral tablet | Drug | GSK2190915 100mg |
| GSK2190915 200mgFilm coated oral tablet | Drug | GSK2190915 1000mg |
| moxifloxacin 400mgFilm coated oral tablet | Drug | moxifloxacin 400mg |
| moxifloxacin placeboFilm coated oral tablet | Drug | GSK2190915 1000mg, GSK2190915 100mg, placebo |
| GSK2190915 placeboFilm coated oral tablet | Drug | GSK2190915 100mg, moxifloxacin 400mg, placebo |
Primary outcome
Change from baseline in QTcF interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 100mg GSK2190915 as compared with time-matched placebo
Time frame: 5 days
8 secondary outcomes
Change from baseline in QTcF interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 1000mg GSK2190915 as compared with time-matched placebo
Time frame: 5 days
Change from baseline in QTcB interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 100mg and 1000mg GSK2190915 as compared with time-matched placebo
Time frame: 5 days
Change from baseline in QTcF interval at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for moxifloxacin as compared with time-matched placebo
Time frame: 5 days
Plasma concentrations of GSK2190915 taken on Day 5 to derive pharmacokinetic parameters including Maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax) and Area under the concentration-time curve over the dosing interval (AUC(0-τ))
Time frame: 5 days
Heart rate and ECG parameters taken on Day 1 and Day 5 compared with concentration of Plasma GSK2190915 to find relationship
Time frame: 5 days
Maximal change from baseline on Day 5 for QTcF and QTcB
Time frame: 5 days
Change from baseline at each timepoint on Day 5 for other cardiac electrophysiological parameters: QT, QRS, RR, PR and ventricular rate
Time frame: 5 days
Assessment of safety and tolerability of GSK2190915 by 12-lead ECGs, vital signs, adverse events and clinical laboratory tests throughout treatment period
Time frame: 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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 GSK2190915 100mg, GSK2190915 200mg and moxifloxacin 400mg in people with Asthma, 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 9 inclusion and 19 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: withdrawn, as of the sponsor's last update on 21 Aug 2013. 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 was withdrawn before enrolling participants, so there are no results.
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 at each timepoint on Day 5 (average of at least 3 12-lead Holter ECG replicates per time point) for 100mg GSK2190915 as compared with time-matched placebo (time frame: 5 days). 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 21 Aug 2013.