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This study is the first administration of GSK610677 to man. The main aim of this clinical study is to investigate the safety and tolerability of different doses of the investigational medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into this study. Individual subjects in each cohort will have up to 3 treatment periods. In each treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo. Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort, there will be a minimum wash out period of at least 10 days. In this period safety and tolerability data will be collected prior to dose to the next level.After safety review meetings between the site and the sponsor following the administration of the 500 ug dose, it was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each subject in Cohort III will undergo a screening visit, one treatment period, and a follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 of Cohort-I | Experimental | Subjects in Sequence 1 will receive Placebo during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
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| Sequence 2 of Cohort-I | Experimental | Subjects in Sequence 2 will receive 10 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
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| Sequence 3 of Cohort-I | Experimental | Subjects in Sequence 3 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. |
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| Sequence 4 of Cohort-I | Experimental | Subjects in Sequence 4 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
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| Sequence 5 of Cohort-II | Experimental | Subjects in Sequence 5 will receive Placebo during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK610677 | Drug | GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples over a period of 48 hours. | Pre-dose, 5, 10, 15, 30 and 45 minutes, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters over a period of the study, including ECG, Telemetry and vital sign. Continuous adverse event monitoring from dosing until study conclusion and follow up, 14-21 days after last dose. | Up to 21 days after last dose | |
| Plasma GSK610677 and GSK1437357 concentrations |
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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 | Berlin | 14050 | Germany |
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| Label | URL |
|---|---|
| Results for study IP2107882 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Sequence 6 of Cohort-II | Experimental | Subjects in Sequence 6 will receive 30 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
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| Sequence 7 of Cohort-II | Experimental | Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. |
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| Sequence 8 of Cohort-II | Experimental | Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
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| Cohort III | Experimental | Subjects in Cohort III after randomization will either receive 1000 microgram GSK610677 or placebo. |
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| Placebo | Drug | Matching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose. |
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| Up to 21 days after last dose |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |