Healthy
Conditions
Keywords
Healthy volunteer
Brief 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.
Interventions
DRUGLFX453 H1
LFX453 high dose cream 1
DRUGLFX453 L1
LFX453 low dose cream 1
DRUGLFX453 H2
LFX453 high dose cream 2
DRUGLFX453 L2
LFX453 low dose cream 2
DRUGImiquimod
Imiquimod cream
DRUGPlacebo 1
Placebo cream 1
DRUGPlacebo 2
Placebo cream 2
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General safety (number of subjects with adverse events) | 14 days | Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death. |
| Local skin tolerability (tolerability score) | 14 days | Summarized statistics on 5-point scale tolerability scores over 14 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All parts: Amount (ng/mL) of LFX453 in plasma | 14 days | Evaluate systemic steady state pharmacokinetics in human after topical administration of LFX453. |
| Part 1 and 2: LFX453 concentrations (ng/g) in the skin | Day 14 and between days 18-21 | LFX453 analyzed in skin. |
| All parts: LFX453 concentration (ng/mL) in urine | Day 14 | LFX453 analyzed in urine. |
Countries
United Kingdom
Outcome results
None listed