Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
Phase 1
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Drug: GW842470XDrug: Placebo
- Registration Number
- NCT00356642
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Repeat dose 2 cohort Placebo 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 Repeat dose 2 cohort GW842470X 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 Repeat dose 3 cohort GW842470X 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 Repeat dose 3 cohort Placebo 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 Single dose 1 cohort GW842470X 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. Single dose 1 cohort Placebo 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. Repeat dose 1 cohort GW842470X 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 Repeat dose 1 cohort Placebo 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Berlin, Germany