Novartis Investigative Site
Graz, Austria
NCT Number: NCT01539915
This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topically applied BCT194 cream (0.5%)
Time frame: Day 1 and day 8
Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints
Time frame: day 1 and day 8
Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints
Time frame: day 1 and day 8
Interstitial fluid will be collected and concentrations of Tumor Necrosis Factor alpha determined determined on Day 1 and Day 8 at several timepoints
Time frame: day 1 and day 8
Treatment areas will be assessed clinically at baseline and Day 8
Time frame: day 1 and day 8
Biopsies of lesional and nonlesional skin will be collected 4 hours post dose on Day 1 and Day 8 for measurement of BCT194 concentration.
Time frame: Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13
Local tolerability assessed using a validated score (0-4) for each treatment area
Safety Issue: Treatment sites will be visually assessed for visible reaction to the treatment.
Novartis Pharmaceuticals
Industry
A Single Center, Open Label Exploratory Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Topically Administered BCT194 in Dermal Interstitial Fluid in Psoriatic Patients Using Open Flow Microperfusion
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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