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Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each dosing period and will remain in the unit until Day 2. Each subject will receive a single dose of each of the four treatments on Day 1 of each treatment period in a randomized fashion. Subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 of each period and return approximately 5-7 days later for the next dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Treatment A will include combination of zanamivir 600 mg IV plus placebo for moxifloxacin |
|
| Treatment B | Experimental | Treatment A will include combination of zanamivir 1200 mg IV plus placebo for moxifloxacin |
|
| Treatment C | Experimental | Treatment C will include zanamivir placebo plus placebo for moxifloxacin |
|
| Treatment D | Experimental | Treatment D will include moxifloxacin plus zanamivir placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 600 mg zanamivir + moxifloxacin placebo | Drug | zanamivir 600 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcF for zanamivir | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcB | 9 weeks | |
| Change from baseline in QTci | 9 weeks | |
| Change from baseline in QT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23553534 | Background | Lou Y, Gan J, Peppercorn A, Gould E, Weller S, Piscitelli SC, Patel P. Effect of intravenous zanamivir on cardiac repolarization. Pharmacotherapy. 2013 Jul;33(7):701-9. doi: 10.1002/phar.1261. Epub 2013 Apr 3. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114346 | Annotated Case Report Form | View IPD |
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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| 1200 mg zanamivir + moxifloxacin placebo | Drug | zanamivir 1200 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose |
|
| zanamivir placebo + moxifloxacin placebo | Drug | zanamivir placebo IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose |
|
| zanamivir placebo + 400 mg moxifloxacin | Drug | moxifloxacin 400 mg administered orally x 1 dose + zanamivir placebo IV over 30 min x 1 dose |
|
| 9 weeks |
| Change from baseline in Heart Rate | 9 weeks |
| Pharmacokinetic parameters of Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of maximum observed concentration from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of time of occurrence of cmax from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of systemic clearance of parent drug from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of volume of distribution in terminal phase from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of terminal phase half-life from serum zanamivir concentration-time data | 9 weeks |
| Pharmacokinetic parameters of Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration (if needed) from plasma moxifloxacin concentration-time data | 9 weeks |
| Pharmacokinetic parameters of area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (if needed) from plasma moxifloxacin concentration-time data | 9 weeks |
| Pharmacokinetic parameters of maximum observed concentration (if needed) from plasma moxifloxacin concentration-time data | 9 weeks |
| Pharmacokinetic parameters of time of occurrence of cmax (if needed) from plasma moxifloxacin concentration-time data | 9 weeks |
| Pharmacokinetic parameters of systemic clearance of parent drug (if needed) from plasma moxifloxacin concentration-time data | 9 weeks |
| Pharmacokinetic parameters of volume of distribution in terminal phase (if needed) from plasma moxifloxacin concentration-time data | 9 weeks |
| Pharmacokinetic parameters of terminal phase half-life (if needed) from plasm moxifloxacin concentration-time data | 9 weeks |
| Safety and tolerability of zanamivir as assessed by change from baseline in 12-lead Electrocardiograms (ECG) | 9 weeks |
| Safety and tolerability of zanamivir as assessed by change from baseline in blood pressure and heart rate | 9 weeks |
| Safety and tolerability of zanamivir as assessed by change from baseline in the collection of adverse events | 9 weeks |
| Safety and tolerability of zanamivir as assessed by change from baseline in toxicity grading of clinical laboratory tests | 9 weeks |
| Results for study 114346 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114346 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114346 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114346 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114346 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114346 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114346 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D053243 | Zanamivir |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D012794 | Sialic Acids |
| D009438 | Neuraminic Acids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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