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A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453

NCT02052687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-05-15

No results posted yet for this study

Summary

The purpose of this first-in human study is to demonstrate systemic and local tolerability and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy subjects.

The current study has been designed with three distinct parts. Part 1 focuses on safety and tolerability of once daily application on the back, prior to moving forward and assessing the safety and tolerability in more sensitive treatment areas in Part 2 or twice daily application in Part 3.

Conditions

  • Healthy

Interventions

DRUG

LFX453 H1

LFX453 high dose cream 1

DRUG

LFX453 L1

LFX453 low dose cream 1

DRUG

LFX453 H2

LFX453 high dose cream 2

DRUG

LFX453 L2

LFX453 low dose cream 2

DRUG

Imiquimod

Imiquimod cream

DRUG

Placebo 1

Placebo cream 1

DRUG

Placebo 2

Placebo cream 2

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United Kingdom

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02052687 on ClinicalTrials.gov