Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis

NCT00356642 | Completed Phase 1

• 1 other identifier: TPD102031
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Dermatitis, Atopic

Keywords

PK; GW842470X; safety; tolerability; PD; Atopic Dermatitis

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• 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

Study Arms (4)

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.

Drug: GW842470X; Drug: Placebo

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

Drug: GW842470X; Drug: Placebo

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

Drug: GW842470X; Drug: Placebo

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

Drug: GW842470X; Drug: Placebo

Interventions

GW842470X DRUG

GW842470X will be available as a yellow smooth water-in-oil cream.

Repeat dose 1 cohort; Repeat dose 2 cohort; Repeat dose 3 cohort; Single dose 1 cohort

Placebo DRUG

GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.

Repeat dose 1 cohort; Repeat dose 2 cohort; Repeat dose 3 cohort; Single dose 1 cohort

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atopic dermatitis patients (moderate to severe) who are otherwise healthy.
• BMI range 18.5-29.9m2 at least 2 index lesions and BSA involvement \>10%.
• day washout of current therapy.

You may not qualify if:

• Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar or any treatment with corticosteroids within 14 days prior to first application except 1% hydrocortisone.
• Patients must not present with any systemic disorders or active skin disease other than atopic dermatitis.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 25670894 DERIVED

Related Links

• Results for study 102031 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 26, 2006
• Study Start: June 10, 2005
• Primary Completion: December 21, 2005
• Study Completion: December 21, 2005
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

DE (1)