Acute Coronary SyndromePhase 1NCT01756495
A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin
A Phase 1 study testing Losmapimod and Moxifloxacin in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corrected QT interval… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Losmapimod and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2013to 23 Apr 2013
- 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
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac safety 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 and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent
- 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 MIU/mL and estradiol <40 pg/mL [<147 pmol/L] is confirmatory)
- Child-bearing potential and is abstinent or agrees to use one of the allowed contraception methods with a failure rate of <1% (Oral contraceptive, either combined or progestogen alone, Injectable progestogen, Implants of etonogestrel or levonorgestrel, Estrogenic vaginal ring, Percutaneous contraceptive patches, Intrauterine device [IUD] or intrauterine system [IUS], Male partner sterilization [vasectomy with documentation of azoospermia] prior to the female subject's entry into the study, and this male is the sole partner for that subject, Male condom combined with a female diaphragm, either with or without a vaginal spermicide [foam, gel, cream or suppository], Male condom combined with a vaginal spermicide [foam, gel, cream or suppository]) 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 the follow-up visit
- Body weight >=50 kg and Body mass index (BMI) within the range 19 to 28 kg/m^2 (inclusive)
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Who cannot join
- Subjects with cardiac conduction abnormalities on the screening 12-lead ECG denoted by any of the following
- QTcB or QTcF >450 msec
- PR interval >200 msec or <=110 msec
- evidence of second- or third- degree atrioventricular block (AVB)
- clinically significant pathological Q-waves (defined as Q-wave >40 msec or depth greater than 0.4 to 0.5 mV)
- evidence of ventricular pre-excitation
Show all 26Show fewer
- electrocardiographic evidence of complete left bundle branch block (LBBB), right bundle branch block (RBBB), incomplete LBBB
- intraventricular conduction delay with QRS duration >110 msec
- bradycardia as defined by sinus rate <45 beats per minute (BPM) or tachycardia as defined by sinus rate >100 BPM
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG
- Subjects with a personal or family history of QTc prolongation, symptomatic cardiac arrhythmias or cardiac arrest
- History of hypersensitivity to moxifloxacin or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- 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 Human immunodeficiency virus (HIV) antibody result within 3 months of screening
- History of regular alcohol consumption within 6 months of the study defined as (For US sites) an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled 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: 30 days, 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
- Unable to refrain from the 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
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- Pregnant females as determined by positive serum human chorionic gonadotropin (hCG) test at screening or prior to dosing
- Lactating females
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
- History of sensitivity to heparin or heparin-induced thrombocytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Phase 1 Double Blind Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects
This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc interval prolongation; therefore, it will serve as a positive control to validate the ability of this study to detect a change in the QTc interval. All subjects will participate in 4 study periods separated by a minimum washout period of 5 days. Each subject will receive one of 4 regimens (A = Losmapimod 7.5 milligram [mg] Twice daily [BID] x 5 days, B = Losmapimod 20 mg Once daily [QD] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14 days after end of Period 4
- Conditions
- Acute Coronary Syndrome
- Being tested
- Losmapimod, Moxifloxacin, Losmapimod matched Placebo, Moxifloxacin Placebo
- Keywords
- QTc,, GW856553 ., P38,
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosmapimodDrug
Wet granulation formulation, Film coated white, 7 mm round, biconvex, plain faced Tablet of 7.5 mg or 10 mg unit dose strength. Taken orally 7.5 mg BID / 20 mg QD for 5 days in one of the 4 study periods
MoxifloxacinDrug
17.2mm x 7.1 mm capsule shaped pink biconvex tablet of 400 mg unit dose strength. Taken orally 400 mg on Day 5 in one of the 4 study periods
Losmapimod matched PlaceboDrug
Direct compression formulation (visually matched to GW856553), Film coated white, 7 mm round, biconvex, plain faced Tablet. Taken orally for 5 days in one of the 4 study periods
Moxifloxacin PlaceboDrug
16 mm x 8 mm capsule shaped to white film coated tablet. Taken orally for 5 days in one of the 4 study periods
| Study group | Role | What they receive |
|---|---|---|
| Losmapimod 7.5 mg | Experimental | Each subject will receive losmapimod 7.5 mg BID orally for 5 days, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days Receives: Drug: Losmapimod |
| Losmapimod 20 mg | Experimental | Each subject will receive losmapimod 20 mg QD orally for 5 days, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days Receives: Drug: Losmapimod |
| Moxifloxacin 400 mg | Active comparator | Each subject will receive moxifloxacin 400 mg orally on Day 5, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | Each subject will receive losmapimod matched placebo and moxifloxacin placebo orally for 5 days, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days Receives: Drug: Losmapimod matched Placebo; Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QT interval corrected for heart rate by Fridericia's formula (QTcF) at each time point for losmapimod 20 mg QD on Day 5 as compared with time matched placebo
Triplicate ECGs will be collected at three baseline pre-dose time points (at -45 min, -30 min and -15 min) on Day 1 of the corresponding study period. Period baseline will be the average of triplicate pre-dose assessments. Triplicate Holter ECGs measurements will be evaluated at 14 post-dose time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and 24 hours) on Day 5 of the corresponding study period and will be averaged prior to calculation of changes from period baseline and statistical analyses
Measured: Baseline and Day 5 of the corresponding study period
Secondary outcomes (15)
Change from baseline in QTcF at each time point for losmapimod 7.5 mg BID on Day 5 as compared with time-matched placebo
Triplicate ECGs will be collected at three baseline pre-dose time points (at -45 min, -30 min and -15 min) on Day 1 of the corresponding study period. Period baseline will be the average of triplicate pre-dose assessments. Triplicate Holter ECGs measurements will be evaluated at 14 post-dose time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and 24 hours) on Day 5 of the corresponding study period and will be averaged prior to calculation of changes from period baseline and statistical analyses
Measured: Baseline and Day 5 of the corresponding study period
Change from baseline in QTcF at each time point for moxifloxacin 400 mg single dose as compared with time-matched placebo
Triplicate ECGs will be collected at three baseline pre-dose time points (at -45 min, -30 min and -15 min) on Day 1 of the corresponding study period. Period baseline will be the average of triplicate pre-dose assessments. Triplicate Holter ECGs measurements will be evaluated at 14 post-dose time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and 24 hours) on Day 5 of the corresponding study period and will be averaged prior to calculation of changes from period baseline and statistical analyses
Measured: Baseline and Day 5 of the corresponding study period
Change from baseline in QT interval corrected for heart rate by Bazett's formula (QTcB) at each time point for losmapimod (7.5 mg BID and 20 mg QD) and moxifloxacin (400 mg) on Day 5 as compared with time matched placebo
Triplicate ECGs will be collected at three baseline pre-dose time points (at 45 min, -30 min and -15 min) on Day 1 of all study periods. Period Baseline will be the average of triplicate pre-dose assessments. Triplicate Holter ECGs measurements will be evaluated at 14 post-dose time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and 24 hours) on Day 5 of all the study period and will be averaged prior to calculation of changes from period baseline and statistical analyses
Measured: Baseline and Day 5 of all 4 study period
Change from baseline at each time point on Day 5 for other cardiac electrophysiological parameters: QT, PR, QRS, heart rate (HR) and ECG waveform morphology for losmapimod (7.5 mg BID and 20 mg QD) and moxifloxacin
Single 12-lead ECG that automatically calculates the heart rate and measures PR, QRS, QT will be taken at 0, 2, 4 and 6 hour time points
Measured: Baseline and Day 5 of all 4 study period
Area under the plasma concentration-time curve (AUC) of losmapimod and its metabolite GSK198602 at doses of 7.5 mg BID and 20 mg QD, as well as 400 mg single dose of moxifloxacin
Pharmacokinetics (PK )Trough samples will be collected pre-dose on Days 3 and 4 of each period
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and approximately 24 hours post-dose on Day 5 of all 4 study period
Maximum observed plasma concentration (Cmax) of losmapimod and its metabolite GSK198602 at doses of 7.5 mg BID and 20 mg QD, as well as 400 mg single dose of moxifloxacin
PK Trough samples will be collected pre-dose on Days 3 and 4 of each period
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and approximately 24 hours post-dose on Day 5 of all 4 study period
Time to Cmax (Tmax) of losmapimod and its metabolite GSK198602 at doses of 7.5 mg BID and 20 mg QD, as well as 400 mg single dose of moxifloxacin
PK Trough samples will be collected pre-dose on Days 3 and 4 of each period
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and approximately 24 hours post-dose on Day 5 of all 4 study period
Model parameters appropriate for concentration-QT analysis of losmapimod, metabolite and moxifloxacin (e.g. slope and intercept)
The relationship between losmapimod as well as GSK198602 plasma concentrations following repeat oral administration and the time-matched drug-placebo difference in QTc interval (∆∆QTc) will be explored graphically. If an apparent concentration-effect relationship exists, a population PK/ (pharmacodynamics) PD model will be established using nonlinear mixed effects modeling techniques with NONMEM software
Measured: Day 5 of all 4 study period
Physical examination findings to assess safety and tolerability of losmapimod and moxifloxacin
A complete physical examination (of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen [liver and spleen], lymph nodes and extremities, height and weight) will occur at the screening and follow up visits. A brief physical examination (of the skin, lungs, cardiovascular system, and abdomen [liver and spleen]) will occur at Day -1
Measured: Up to Day 49
12-lead ECGs measurements to assess safety and tolerability of losmapimod and moxifloxacin
As part of safety assessments, single 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals
Measured: Up to Day 49
Clinical laboratory test measurements to assess safety and tolerability of losmapimod and moxifloxacin
Samples will be collected at Screening, Day -1, follow-up for assessing safety
Measured: Up to Day 49
Clinical monitoring/observation
The safety and tolerability of repeat oral doses of losmapimod 20mg QD and 7.5mg BID, as well as a single dose of moxifloxacin
Measured: Up to Day 49
Number of subjects with adverse events
The safety and tolerability will be assessed by adverse events (AEs) of repeat oral doses of losmapimod 20mg QD and 7.5mg BID, as well as a single dose of moxifloxacin
Measured: Up to Day 49
Blood pressure measurements to assess safety and tolerability of losmapimod and moxifloxacin
One measurement of blood pressure will be taken at Screening, Day -1 and Follow Up at the 0 hour timepoint on Day -1 and Follow up. Blood pressure measurement will be taken at 0, 2, 4 and 6 hour time points on Days 1, 4 and 5
Measured: Up to Day 49
HR measurements to assess safety and tolerability of losmapimod and moxifloxacin
One measurement of HR will be taken at Screening, Day -1 and Follow Up at the 0 hour timepoint on Day -1 and Follow up. HR measurement will be taken at 0, 2, 4 and 6 hour time points on Days 1, 4 and 5
Measured: Up to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study start10 Jan 2013
- Primary completion23 Apr 2013
- Study completion23 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 56 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
- NCT01756495
- Sponsor's protocol ID
- 116628
- Status last verified
- Jun 2017
- First submitted
- 20 Dec 2012
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- 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 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Phase 1 Double Blind Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01756495
- Acronym / sponsor ID
- 116628
- Conditions
- Acute Coronary Syndrome
- Keywords
- QTc,, GW856553 ., P38,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 23 Apr 2013 (actual)
- Study completion
- 23 Apr 2013 (actual)
- First posted
- 27 Dec 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 will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc interval prolongation; therefore, it will serve as a positive control to validate the ability of this study to detect a change in the QTc interval. All subjects will participate in 4 study periods separated by a minimum washout period of 5 days. Each subject will receive one of 4 regimens (A = Losmapimod 7.5 milligram [mg] Twice daily [BID] x 5 days, B = Losmapimod 20 mg Once daily [QD] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14 days after end of Period 4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Losmapimod 7.5 mg | Experimental | Drug: LosmapimodEach subject will receive losmapimod 7.5 mg BID orally for 5 days, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days |
| Losmapimod 20 mg | Experimental | Drug: LosmapimodEach subject will receive losmapimod 20 mg QD orally for 5 days, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days |
| Moxifloxacin 400 mg | Active comparator | Drug: MoxifloxacinEach subject will receive moxifloxacin 400 mg orally on Day 5, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days |
| Placebo | Placebo comparator | Drug: Losmapimod matched Placebo, Drug: Moxifloxacin PlaceboEach subject will receive losmapimod matched placebo and moxifloxacin placebo orally for 5 days, in one of the 4 study periods (per randomization sequence) separated by a minimum washout period of 5 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac safety 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 and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent
- A female subject is eligible to participate if she is of
- Body weight >=50 kg and Body mass index (BMI) within the range 19 to 28 kg/m^2 (inclusive)
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Key exclusion criteria (26 listed)
- Subjects with cardiac conduction abnormalities on the screening 12-lead ECG denoted by any of the following
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG
- Subjects with a personal or family history of QTc prolongation, symptomatic cardiac arrhythmias or cardiac arrest
- History of hypersensitivity to moxifloxacin or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
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 |
|---|---|---|
| LosmapimodWet granulation formulation, Film coated white, 7 mm round, biconvex, plain faced Tablet of 7.5 mg or 10 mg unit dose strength. Taken orally 7.5 mg BID / 20 mg QD for 5 days in one of the 4 study periods | Drug | Losmapimod 20 mg, Losmapimod 7.5 mg |
| Moxifloxacin17.2mm x 7.1 mm capsule shaped pink biconvex tablet of 400 mg unit dose strength. Taken orally 400 mg on Day 5 in one of the 4 study periods | Drug | Moxifloxacin 400 mg |
| Losmapimod matched PlaceboDirect compression formulation (visually matched to GW856553), Film coated white, 7 mm round, biconvex, plain faced Tablet. Taken orally for 5 days in one of the 4 study periods | Drug | Placebo |
| Moxifloxacin Placebo16 mm x 8 mm capsule shaped to white film coated tablet. Taken orally for 5 days in one of the 4 study periods | Drug | Placebo |
Primary outcome
Change from baseline in QT interval corrected for heart rate by Fridericia's formula (QTcF) at each time point for losmapimod 20 mg QD on Day 5 as compared with time matched placebo
Time frame: Baseline and Day 5 of the corresponding study period
Triplicate ECGs will be collected at three baseline pre-dose time points (at -45 min, -30 min and -15 min) on Day 1 of the corresponding study period. Period baseline will be the average of triplicate pre-dose assessments. Triplicate Holter ECGs measurements will be evaluated at 14 post-dose time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and 24 hours) on Day 5 of the corresponding study period and will be averaged prior to calculation of changes from period baseline and statistical analyses
15 secondary outcomes
Change from baseline in QTcF at each time point for losmapimod 7.5 mg BID on Day 5 as compared with time-matched placebo
Time frame: Baseline and Day 5 of the corresponding study period
Change from baseline in QTcF at each time point for moxifloxacin 400 mg single dose as compared with time-matched placebo
Time frame: Baseline and Day 5 of the corresponding study period
Change from baseline in QT interval corrected for heart rate by Bazett's formula (QTcB) at each time point for losmapimod (7.5 mg BID and 20 mg QD) and moxifloxacin (400 mg) on Day 5 as compared with time matched placebo
Time frame: Baseline and Day 5 of all 4 study period
Change from baseline at each time point on Day 5 for other cardiac electrophysiological parameters: QT, PR, QRS, heart rate (HR) and ECG waveform morphology for losmapimod (7.5 mg BID and 20 mg QD) and moxifloxacin
Time frame: Baseline and Day 5 of all 4 study period
Area under the plasma concentration-time curve (AUC) of losmapimod and its metabolite GSK198602 at doses of 7.5 mg BID and 20 mg QD, as well as 400 mg single dose of moxifloxacin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and approximately 24 hours post-dose on Day 5 of all 4 study period
Maximum observed plasma concentration (Cmax) of losmapimod and its metabolite GSK198602 at doses of 7.5 mg BID and 20 mg QD, as well as 400 mg single dose of moxifloxacin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and approximately 24 hours post-dose on Day 5 of all 4 study period
Time to Cmax (Tmax) of losmapimod and its metabolite GSK198602 at doses of 7.5 mg BID and 20 mg QD, as well as 400 mg single dose of moxifloxacin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18 and approximately 24 hours post-dose on Day 5 of all 4 study period
Model parameters appropriate for concentration-QT analysis of losmapimod, metabolite and moxifloxacin (e.g. slope and intercept)
Time frame: Day 5 of all 4 study period
Physical examination findings to assess safety and tolerability of losmapimod and moxifloxacin
Time frame: Up to Day 49
12-lead ECGs measurements to assess safety and tolerability of losmapimod and moxifloxacin
Time frame: Up to Day 49
Clinical laboratory test measurements to assess safety and tolerability of losmapimod and moxifloxacin
Time frame: Up to Day 49
Clinical monitoring/observation
Time frame: Up to Day 49
Number of subjects with adverse events
Time frame: Up to Day 49
Blood pressure measurements to assess safety and tolerability of losmapimod and moxifloxacin
Time frame: Up to Day 49
HR measurements to assess safety and tolerability of losmapimod and moxifloxacin
Time frame: Up to Day 49
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 7 Jun 2017.
- 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.
- Results for study 116628 can be found on the GSK Clinical Study Register.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.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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 Losmapimod and Moxifloxacin in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 1 site in United States.
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 7 inclusion and 26 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 7 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 States. 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 QT interval corrected for heart rate by Fridericia's formula (QTcF) at each time point for losmapimod 20 mg QD on Day 5 as compared with time matched placebo (time frame: Baseline and Day 5 of the corresponding study period). 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 7 Jun 2017.