Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: BCT194

• Registration Number: NCT01539915
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-11
• Status Verified: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-27
• Last Update Submitted: 2012-02-27
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCT194	BCT194	-

Primary Outcome Measures

Name	Time	Method
change in Maximum dermal interstitial concentration of BCT194	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
Area under the curve interstitial concentrations of BCT194	day 1 and day 8	Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints

Secondary Outcome Measures

Name	Time	Method
Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)	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
Change in plaque PASI scores of psoriasis lesions	day 1 and day 8	Treatment areas will be assessed clinically at baseline and Day 8
BCT194 concentrations in skin biopsies	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.
Change in Local tolerability score	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇹 Graz, Austria