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This study will invite two groups of volunteers to participate.
The data from one group of volunteers will be used to find out how much study drug, known as GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected to find out if the level of cetain blood cells, known as neutrophils, change significantly after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64 years of age.
The data from the other group of volunteers will be used to find out if taking the study drug, GSK1325756, twice in one day with or without food, makes a difference to the level of study drug in the blood. This group of volunteers will also provide data to find out if any study drug metabolites are present in the bile, a fluid secreted by the liver. This group of volunteers will be aged 65 to 80 years of age.
The current study will be conducted in two parts. In Part A - Cohort 1, healthy fed subjects aged 40 to 64 years (inclusive) will be enrolled to evaluate both the pharmacokinetics and pharmacodynamics of twice daily oral administration of GSK1325756 compared to matching placebo. In Part B - Cohort 2, healthy elderly subjects aged 65 to 80 years (inclusive) will be enrolled to evaluate the pharmacokinetic profile of twice daily oral administration of GSK1325756 for administered under fed and fasted conditions. Parts A and B may be performed in parallel.
The approximate duration of the current study is expected to be between 64 and 74 days. The study will require subjects to complete a screening visit within 30 days, followed by Part A - Cohort 1 enrolment requiring 3 x (3 day treatment period + 7 day washout period) or Part B Cohort 2 enrolment requiring 2 x (3 day treatment period + 7 day washout period). All subjects will complete a follow up visit within seven to 14 days of last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Part A - Cohort 1 subjects will be administered GSK1325756 matching placebo tablets twice daily following a light meal for one day in accordance with the randomization schedule. |
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| GSK1325756 200 mg | Experimental | Part A - Cohort 1 subjects will be administered GSK1325756 200 mg immediate release tablets twice daily following a light meal for one day in accordance with the randomization schedule. |
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| GSK1325756 50 mg | Experimental | Part A - Cohort 1 subjects will be administered GSK1325756 50 mg immediate release tablets twice daily following a light meal for one day in accordance with the randomization schedule. |
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| GSK1325756 100 mg | Experimental | Part B - Cohort 2 subjects will be administered GSK1325756 100 mg following a light meal (Fed) or in the fasted state twice daily for one day in accordance with the randomization schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1325756 | Drug | GSK1325756 will be available as white, film coated immediate release tablets with dose strengths of 50 mg, 100 mg and 200 mg. The tablets will be administered twice daily by oral route with 240 milliliters of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics | 48 hours | |
| Adverse Events | 48 hours |
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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 | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22670830 | Background | Bloomer JC, Nash M, Webb A, Miller BE, Lazaar AL, Beaumont C, Guiney WJ. Assessment of potential drug interactions by characterization of human drug metabolism pathways using non-invasive bile sampling. Br J Clin Pharmacol. 2013 Feb;75(2):488-96. doi: 10.1111/j.1365-2125.2012.04352.x. |
| Label | URL |
|---|---|
| Results for study 114922 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114922 | Study Protocol | 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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| 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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| ID | Term |
|---|---|
| C581951 | danirixin |
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| Placebo tablet | Drug | Placebo will be available as white film coated GSK1325756 matching tablet which will be administered twice daily by oral route with 240 milliliters of water. |
|
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114922 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114922 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114922 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114922 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114922 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114922 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |