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The purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor of phosphodiesterase 4 (PDE4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose 1 cohort | Experimental | Subjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1. |
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| Repeat dose 1 cohort | Experimental | Subjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1 |
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| Repeat dose 2 cohort | Experimental | Subjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1 |
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| Repeat dose 3 cohort | Experimental | Subjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW842470X | Drug | GW842470X will be available as a yellow smooth water-in-oil cream. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal physical examination findings | Up to Day 22 | |
| Number of subjects with abnormal blood pressure | Up to Day 22 | |
| Number of subjects with abnormal heart rate | Up to Day 22 | |
| Number of subjects with abnormal 12-lead ECG assessment | Up to Day 22 | |
| Number of subjects with abnormal findings on lead II cardiac monitoring | Up to Day 10 | |
| Number of subjects with abnormal clinical laboratory tests | Up to Day 22 | |
| AUC | Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10 | |
| Cmax | Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to max concentration and terminal half-life | Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10 | |
| SCORAD | Up to Day 10 |
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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 | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25670894 | Derived | Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M. Airway inflammation in Japanese COPD patients compared with smoking and nonsmoking controls. Int J Chron Obstruct Pulmon Dis. 2015 Jan 23;10:185-92. doi: 10.2147/COPD.S74557. eCollection 2015. |
| Label | URL |
|---|---|
| Results for study 102031 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | GW842470X matching placebo will be available as a yellow smooth water-in-oil cream. |
|
| BSA determination | Up to Day 10 |
| clinical photography | Up to Day 10 |
| measurement of barrier function using trans-epidermal water loss (TEWL) | Up to Day 10 |
| skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE) | Up to Day 10 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |