Infection, Human Immunodeficiency VirusPhase 1NCT02027454
Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction
A Phase 1 study testing GSK1265744 and Moxifloxacin in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- GSK1265744 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females aged between 18 and 55 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.
- Body weight >=50 kilograms (kg) for men and >= 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/meter^2 (inclusive).
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral oophorectomy or hysterectomy [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli international unit (MlU)/mililiter (m) and estradiol < 40 picogram/mL (<147 picomoles/L) is confirmatory] OR has only same-sex partners, when this is her preferred and usual lifestyle.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until 21 days post-last dose.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams 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.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Use of tobacco- or nicotine-containing products within 6 months prior to screening.
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- A positive pre-study drug/alcohol screen.
- A positive test for human immuno virus antibody.
- Subjects with an alanine aminotransferase, alkaline phosphatase and bilirubin >=1.5xupper limit of normal (ULN) (isolated bilirubin <1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin >35%).
- The subject's systolic blood pressure is outside the range of 90 to140 milimeter of mercury (mmHg) or diastolic blood pressure is outside the range of 45 to 90mmHg or heart rate is outside the range of 50 to 100 beats per minute (bpm) for female subjects or 45 to 100 bpm for male subjects.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): are: male subjects with Heart rate <45 and >100 bpm and female subjects with heart rate <50 and >100 bpm, PR <120 and >220 milliseconds (msec), QRS duration <70 and >120 msec, QTcB >450 msec.
- Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
- Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [2nd degree or higher], Wolf Parkinson White syndrome).
- Sinus Pauses > 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
- Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
- Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Study to Evaluate the Effect of GSK1265744 150mg Administered Orally Every 12h x 3 Doses on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin
This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead continuous digital data in healthy adults. This study will evaluate the effect of three doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. This study consists of three treatment periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last dosing. The total duration of study including follow-up visit will be approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical assessments.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- GSK1265744, GSK1265744 matching placebo, Moxifloxacin
- Keywords
- GSK1265744, HIV, placebo, cardiac repolarization, 12-lead ECG, moxifloxacin, QTc
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1265744Drug
White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses.
GSK1265744 matching placeboDrug
GSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose).
MoxifloxacinDrug
Dull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants in this arm will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). Receives: Drug: GSK1265744; Drug: GSK1265744 matching placebo; Drug: Moxifloxacin |
| Sequence 2 | Experimental | Participants in this arm will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). Receives: Drug: GSK1265744; Drug: GSK1265744 matching placebo; Drug: Moxifloxacin |
| Sequence 3 | Experimental | Participants in this arm will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). Receives: Drug: GSK1265744; Drug: GSK1265744 matching placebo; Drug: Moxifloxacin |
| Sequence 4 | Experimental | Participants in this arm will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). Receives: Drug: GSK1265744; Drug: GSK1265744 matching placebo; Drug: Moxifloxacin |
| Sequence 5 | Experimental | Participants in this arm will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). Receives: Drug: GSK1265744; Drug: GSK1265744 matching placebo; Drug: Moxifloxacin |
| Sequence 6 | Experimental | Participants in this arm will receive treatment C in period 1, treatment B in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). Receives: Drug: GSK1265744; Drug: GSK1265744 matching placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QT duration corrected for heart rate by Fridericia's formulas (QTcF) for GSK1265744
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF interval will be obtained by digital electrocardiograms (ECG) obtained through 12 lead holter monitoring machine. Triplicate ECGs will be evaluated at each time point
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days)
Secondary outcomes (15)
Change from baseline in QT duration corrected for heart rate by Bazett's formula (QTcB), individual corrected QTc ( QTci) values, QT, QRS, and PR for GSK1265744
Single ECG will be obtained at all timepoints during the study using an ECG machine that automatically measures PR (beginning of P wave to the beginning of the next QRS), QRS (beginning of Q to the end of the S wave), QT, and QTc intervals.
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in heart rate (HR) for GSK1265744
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the heart rate. Heart rate is defined as the number of heartbeats per unit of time, usually per minute.
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in QTcF, QTcB, QTci, QT, QRS, and PR for placebo
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the QTcF, QTcB, QTCi, QT, QRS, PR intervals
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in HR for placebo
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the heart rate. Heart rate is defined as the number of heartbeats per unit of time, usually per minute.
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in QTcF, QTcB, QTci, QT, QRS, and PR for Moxifloxacin
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the QTcF, QTcB, QTCi, QT, QRS, PR intervals
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in HR for Moxifloxacin.
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the heart rate. Heart rate is defined as the number of heartbeats per unit of time, usually per minute.
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Composite of pharmacokinetic (PK) parameters for GSK1265744.
PK parameters include: area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]), area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-infinity]), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), apparent clearance following oral dosing (CL/F), apparent volume of distribution at steady state after oral administration (Vdz/F), and terminal phase half-life (t1/2) from plasma concentrations of GSK1265744.
Measured: Blood samples will be collected at following time points: Day 1 pre-dose (15 minutes prior to first dose 1), and at Day 2 pre-dose (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
Composite of PK parameters for Moxifloxacin (if needed).
PK parameters include: AUC (0-t), AUC (0-infinity), Cmax, tmax, CL/F, Vdz/f, and t1/2.
Measured: Blood samples will be collected on Day 2 at pre-dose, 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
12-lead ECG as a measure of safety and tolerability.
12-lead ECGs will be performed with the subject in a semi-supine position having rested in this position for at least 10 minutes beforehand. ECGs will be obtained using an ECG machine that automatically calculates the QTcF, QTcB, QTCi, QT, QRS, PR intervals and HR.
Measured: Up to 62 days.
Vital sign as a measure of safety and tolerability.
Vital sign measurement include: blood pressure and heart rate.
Measured: Up to 62 days.
Number participants with adverse events as a measure of safety and tolerability.
AEs will be collected from the start of Study Treatment and until the follow-up contact.
Measured: Up to 62 days.
Clinical laboratory parameters assessment as a measure of safety and tolerability.
Clinical laboratory assessment include: hematology, clinical chemistry, urinalysis and additional parameters as needed.
Measured: Up to 62 days.
Change from baseline in QTcF, QTcB and QTci for GSK1265744
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the QTcF, QTcB, and QTCi intervals.
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Difference between GSK1265744 and placebo in terms of change from baseline in QTcF, QTcB and QTci.
Difference between GSK12657744 and placebo in terms of change from baseline in QTcF, QTcB and QTci will be measured to characterize pharmacodynamic (PD) relationship between exposure of GSK1265744 and changes in QTcF, QTcB and QTci
Measured: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Plasma concentration profile as assessed from composite of PK parameters of GSK1265744.
Plasma concentration profile of GSK1265744 will be assessed to characterize PK/PD relationship between exposure of GSK1265744 and changes in QTcF, QTcB and QTci. PK parameters to be assessed for plasma concentration profile are: area under the concentration-time curve from zero to 24 hours (AUC [0-24]), AUC (0-t), AUC (0-infinity), and Cmax.
Measured: Blood samples will be collected at following time points: Day 1 pre-dose (15 minutes prior to first dose 1), and at Day 2 pre-dose (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027454
- Sponsor's protocol ID
- 117009
- Status last verified
- Jun 2014
- First submitted
- 7 Nov 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of GSK1265744 150mg Administered Orally Every 12h x 3 Doses on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin
- ClinicalTrials.gov ID
- NCT02027454
- Acronym / sponsor ID
- 117009
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- GSK1265744, HIV, placebo, cardiac repolarization, 12-lead ECG, moxifloxacin, QTc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jan 2014 (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 being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead continuous digital data in healthy adults. This study will evaluate the effect of three doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. This study consists of three treatment periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last dosing. The total duration of study including follow-up visit will be approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: GSK1265744, Drug: GSK1265744 matching placebo, Drug: MoxifloxacinParticipants in this arm will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 2 | Experimental | Drug: GSK1265744, Drug: GSK1265744 matching placebo, Drug: MoxifloxacinParticipants in this arm will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 3 | Experimental | Drug: GSK1265744, Drug: GSK1265744 matching placebo, Drug: MoxifloxacinParticipants in this arm will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 4 | Experimental | Drug: GSK1265744, Drug: GSK1265744 matching placebo, Drug: MoxifloxacinParticipants in this arm will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 5 | Experimental | Drug: GSK1265744, Drug: GSK1265744 matching placebo, Drug: MoxifloxacinParticipants in this arm will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 6 | Experimental | Drug: GSK1265744, Drug: GSK1265744 matching placebo, Drug: MoxifloxacinParticipants in this arm will receive treatment C in period 1, treatment B in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and females aged between 18 and 55 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.
- Body weight >=50 kilograms (kg) for men and >= 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/meter^2 (inclusive).
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral oophorectomy or hysterectomy [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli international unit (MlU)/mililiter (m) and estradiol < 40 picogram/mL (<147 picomoles/L) is confirmatory] OR has only same-sex partners, when this is her preferred and usual lifestyle.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until 21 days post-last dose.
Key exclusion criteria (18 listed)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams 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.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, 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 |
|---|---|---|
| GSK1265744White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| GSK1265744 matching placeboGSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose). | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| MoxifloxacinDull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Change from baseline in QT duration corrected for heart rate by Fridericia's formulas (QTcF) for GSK1265744
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days)
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF interval will be obtained by digital electrocardiograms (ECG) obtained through 12 lead holter monitoring machine. Triplicate ECGs will be evaluated at each time point
15 secondary outcomes
Change from baseline in QT duration corrected for heart rate by Bazett's formula (QTcB), individual corrected QTc ( QTci) values, QT, QRS, and PR for GSK1265744
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in heart rate (HR) for GSK1265744
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in QTcF, QTcB, QTci, QT, QRS, and PR for placebo
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in HR for placebo
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in QTcF, QTcB, QTci, QT, QRS, and PR for Moxifloxacin
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in HR for Moxifloxacin.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Composite of pharmacokinetic (PK) parameters for GSK1265744.
Time frame: Blood samples will be collected at following time points: Day 1 pre-dose (15 minutes prior to first dose 1), and at Day 2 pre-dose (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
Composite of PK parameters for Moxifloxacin (if needed).
Time frame: Blood samples will be collected on Day 2 at pre-dose, 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
12-lead ECG as a measure of safety and tolerability.
Time frame: Up to 62 days.
Vital sign as a measure of safety and tolerability.
Time frame: Up to 62 days.
Number participants with adverse events as a measure of safety and tolerability.
Time frame: Up to 62 days.
Clinical laboratory parameters assessment as a measure of safety and tolerability.
Time frame: Up to 62 days.
Change from baseline in QTcF, QTcB and QTci for GSK1265744
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Difference between GSK1265744 and placebo in terms of change from baseline in QTcF, QTcB and QTci.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Plasma concentration profile as assessed from composite of PK parameters of GSK1265744.
Time frame: Blood samples will be collected at following time points: Day 1 pre-dose (15 minutes prior to first dose 1), and at Day 2 pre-dose (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
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 16 Jun 2014.
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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
ViiV Healthcare
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 GSK1265744 and Moxifloxacin in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare 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 6 inclusion and 18 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 16 Jun 2014. 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. 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 duration corrected for heart rate by Fridericia's formulas (QTcF) for GSK1265744 (time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 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 16 Jun 2014.