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This study is a single dose evaluation using an open label dose escalating design. Cohort1 will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg). Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2 hours after cessation of the intravenous infusion. PK measurements and measurement of erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30 minute intervals during the infusion of GW328267X up to and including 1 hour after cessation of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be done.
Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1. It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort 2 will consist of 3 healthy male volunteers and the study procedures for this additional Cohort will be the same as that described for Cohort 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg), and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg) |
|
| Cohort 2 | Experimental | Dose to be determined after analysis of Cohort 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | 30mins run-in period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability including number of subjects with adverse events assessment | baseline, Day 1, Day 2 and Day 10 | |
| Safety and tolerability including change from baseline and number subjects with abnormal clinical safety laboratory data | baseline, Day 1, Day 2 and Day 10 | |
| Safety and tolerability, including change from baseline and number of subjects with abnormal ECG assessments | baseline, Day 1, Day 2 and Day 10 | |
| Safety and tolerability, including change from baseline and number of subjects with abnormal vital signs (blood pressure and heart rate) assessments | baseline, Day 1, Day 2 and Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate changes from baseline during intravenous infusion of GW328267X | baseline, Day 1, Day 2 and Day 10 | |
| Platelet aggregation parameters | Pre-dose, Day 1 5.5 hr, Day 2 | |
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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 | Cambridge | CB2 2GG | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 115387 can be found on the GSK Clinical Study Register. | View source |
| 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 |
|---|---|---|---|
| 115387 | Individual Participant Data Set | 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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| GW328267X (total dose of 12mcg) |
| Drug |
8 mcg/h for 1.5 hours (total dose of 12mcg) |
|
| GW328267X (total dose of 40mcg) | Drug | 10 mcg/h for 4 hours (total dose of 40 mcg) |
|
| Erythropoietin levels |
| Screening, Pre-dose, Day 2, Follow Up |
| Levels of GW328267X in plasma | baseline, Day 1 and Day 2 (24hrs) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115387 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115387 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115387 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115387 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115387 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115387 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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