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

27. september 2017 opdateret af: GlaxoSmithKline

A Randomised, Single-Blind, Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Ten Day Repeat Topical Applications of GW842470X Cream on the Skin of Patients With Atopic Dermatitis

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 10117
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 67 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • 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%.
  • 14 day washout of current therapy.

Exclusion criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single dose 1 cohort
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.
Medicin: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.
Medicin: Placebo
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
Eksperimentel: Repeat dose 1 cohort
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
Medicin: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.
Medicin: Placebo
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
Eksperimentel: Repeat dose 2 cohort
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
Medicin: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.
Medicin: Placebo
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
Eksperimentel: Repeat dose 3 cohort
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
Medicin: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.
Medicin: Placebo
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of subjects with abnormal physical examination findings
Tidsramme: Up to Day 22
Up to Day 22
Number of subjects with abnormal blood pressure
Tidsramme: Up to Day 22
Up to Day 22
Number of subjects with abnormal heart rate
Tidsramme: Up to Day 22
Up to Day 22
Number of subjects with abnormal 12-lead ECG assessment
Tidsramme: Up to Day 22
Up to Day 22
Number of subjects with abnormal findings on lead II cardiac monitoring
Tidsramme: Up to Day 10
Up to Day 10
Number of subjects with abnormal clinical laboratory tests
Tidsramme: Up to Day 22
Up to Day 22
AUC
Tidsramme: 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
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
Tidsramme: 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
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

Sekundære resultatmål

Resultatmål
Tidsramme
Time to max concentration and terminal half-life
Tidsramme: 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
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
Tidsramme: Up to Day 10
Up to Day 10
BSA determination
Tidsramme: Up to Day 10
Up to Day 10
clinical photography
Tidsramme: Up to Day 10
Up to Day 10
measurement of barrier function using trans-epidermal water loss (TEWL)
Tidsramme: Up to Day 10
Up to Day 10
skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
Tidsramme: Up to Day 10
Up to Day 10

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2005

Primær færdiggørelse (Faktiske)

21. december 2005

Studieafslutning (Faktiske)

21. december 2005

Datoer for studieregistrering

Først indsendt

25. juli 2006

Først indsendt, der opfyldte QC-kriterier

25. juli 2006

Først opslået (Skøn)

26. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TPD102031

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