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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Part 1: LFX453/placebo

once daily: LFX453 cream 1 high dose / LFX453 cream 1 low dose /Placebo 1 / LFX453 cream 2 high dose / LFX453 cream 2 low dose / Placebo 2

Group Type EXPERIMENTAL

LFX453 H1

Intervention Type DRUG

LFX453 high dose cream 1

LFX453 L1

Intervention Type DRUG

LFX453 low dose cream 1

LFX453 H2

Intervention Type DRUG

LFX453 high dose cream 2

LFX453 L2

Intervention Type DRUG

LFX453 low dose cream 2

Placebo 1

Intervention Type DRUG

Placebo cream 1

Placebo 2

Intervention Type DRUG

Placebo cream 2

Part 2 groupA: LFX453/placebo

once daily: LFX453 cream 1 / Placebo 1

Group Type EXPERIMENTAL

LFX453 H1

Intervention Type DRUG

LFX453 high dose cream 1

LFX453 L1

Intervention Type DRUG

LFX453 low dose cream 1

LFX453 H2

Intervention Type DRUG

LFX453 high dose cream 2

LFX453 L2

Intervention Type DRUG

LFX453 low dose cream 2

Placebo 1

Intervention Type DRUG

Placebo cream 1

Placebo 2

Intervention Type DRUG

Placebo cream 2

Part 2 groupB: LFX453/placebo

once daily: LFX453 cream 2 / Placebo 2

Group Type EXPERIMENTAL

LFX453 H1

Intervention Type DRUG

LFX453 high dose cream 1

LFX453 L1

Intervention Type DRUG

LFX453 low dose cream 1

LFX453 H2

Intervention Type DRUG

LFX453 high dose cream 2

LFX453 L2

Intervention Type DRUG

LFX453 low dose cream 2

Placebo 1

Intervention Type DRUG

Placebo cream 1

Placebo 2

Intervention Type DRUG

Placebo cream 2

Part 2 groupC: LFX453/LFX453

once daily: LFX453 cream 1 / LFX453 cream 2

Group Type EXPERIMENTAL

LFX453 H1

Intervention Type DRUG

LFX453 high dose cream 1

LFX453 L1

Intervention Type DRUG

LFX453 low dose cream 1

LFX453 H2

Intervention Type DRUG

LFX453 high dose cream 2

LFX453 L2

Intervention Type DRUG

LFX453 low dose cream 2

Part 2 groupD: Imiquimod

once daily: imiquimod cream

Group Type OTHER

Imiquimod

Intervention Type DRUG

Imiquimod cream

Part 3: LFX453/placebo

twice daily: LFX453 cream 1 high dose / LFX453 cream 1 low dose /Placebo 1 / LFX453 cream 2 high dose / LFX453 cream 2 low dose / Placebo 2

Group Type EXPERIMENTAL

LFX453 H1

Intervention Type DRUG

LFX453 high dose cream 1

LFX453 L1

Intervention Type DRUG

LFX453 low dose cream 1

LFX453 H2

Intervention Type DRUG

LFX453 high dose cream 2

LFX453 L2

Intervention Type DRUG

LFX453 low dose cream 2

Placebo 1

Intervention Type DRUG

Placebo cream 1

Placebo 2

Intervention Type DRUG

Placebo cream 2

Interventions

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LFX453 H1

LFX453 high dose cream 1

Intervention Type DRUG

LFX453 L1

LFX453 low dose cream 1

Intervention Type DRUG

LFX453 H2

LFX453 high dose cream 2

Intervention Type DRUG

LFX453 L2

LFX453 low dose cream 2

Intervention Type DRUG

Imiquimod

Imiquimod cream

Intervention Type DRUG

Placebo 1

Placebo cream 1

Intervention Type DRUG

Placebo 2

Placebo cream 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects of non-childbearing potential, 18 to 65 years of age inclusive (at the time of the screening visit), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Male subjects must agree to total abstinence from male:female intercourse or agree to use a condom during drug dosing and for four weeks after dosing has stopped.

Exclusion Criteria

* History of serious allergic reaction to any drug.
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* History of any atopic dermatitis (only within the last 2 years), autoimmune disease, psoriasis or erythema multiforme.
* Presence of skin disease (e.g. warts) or skin features on treatment areas that may affect local tolerability or the ability of the investigator to evaluate local tolerability.
* History of heart failure, left ventricular dysfunction or known family history or known presence of long QT syndrome.
* A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening or baseline:

* 2nd or 3rd degree AV-block
* PR \> 200 msec
* QRS complex \> 120 msec
* QTcF \> 450 msec (males)
* QTcF \> 460 msec (females)
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes