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This is a single-center, randomized, two part, double-blind, crossover study in healthy adult subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function comparing with placebo using echocardiography as a primary assessment modality
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | GSK2336805 150mg |
|
| Treatment B | Placebo Comparator | GSK2336805 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2336805 150mg | Drug | Single Dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with a change in ejection fraction greater than 10 percent | Echocardiographic measures of contractility | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with electrocardiogram (ECG) parameters out of range | Cardiovascular measures | 3 hours |
| Number of subjects with vital signs out of range | Cardiovascular measures |
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Inclusion Criteria:
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
Exclusion Criteria:
Males-Heart rate less than 45 and greater than 100 beats per minute (bpm). Females-Heart rate less than 50 and greater than 100 bpm 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, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome). Sinus Pauses greater than 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 ( greater than or equal to 3 consecutive ventricular ectopic beats).](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23856771 | Derived | Wilfret DA, Adkison KK, Jones LA, Lou Y, Gan J, Spreen W. Echocardiogram study to evaluate the effect of the novel hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy subjects. Antimicrob Agents Chemother. 2013 Oct;57(10):5141-3. doi: 10.1128/AAC.00668-13. Epub 2013 Jul 15. |
| Label | URL |
|---|---|
| Results for study 115535 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000595241 | GSK2336805 |
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| Other |
Single Dose |
|
| 24 hours |
| Number of subjects with adverse events | tolerability | 24 hours |
| Number of subjects using concurrent medication | Concomitant medications | 24 hours |
| Number of subjects with laboratory values out of range | Labs | 24 hours |
| Area under the curve (0-24) | PK parameter | 24 hours |
| Maximum observed concentration (Cmax) | PK parameter | 24 hours |
| Terminal phase half-life | PK parameter | 24 hours |
| Lag time before observation of drug concentrations in sampled matrix | PK parameter | 24 hours |
| Time of occurrence of Cmax | PK parameter | 24 hours |
| Concentration at 24 hours | PK parameter | 24 hours |
| Correlation between concentration and various safety parameters | Safety, PK | 24 hours |
| B-type natriuretic peptide (BNP) lab result | Cardiac biomarkers | 24 hours |
| Troponin lab results | Cardiac biomarkers | 24 hours |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |