A Phase 1 interventional study of LFX453 H1 and LFX453 L1 in Healthy, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-15.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Basic science
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.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening or baseline:
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
Drug: LFX453 H1 · Drug: LFX453 L1 · Drug: LFX453 H2 · Drug: LFX453 L2 · Drug: Placebo 1 · Drug: Placebo 2
once daily: LFX453 cream 1 / Placebo 1
Drug: LFX453 H1 · Drug: LFX453 L1 · Drug: LFX453 H2 · Drug: LFX453 L2 · Drug: Placebo 1 · Drug: Placebo 2
once daily: LFX453 cream 2 / Placebo 2
Drug: LFX453 H1 · Drug: LFX453 L1 · Drug: LFX453 H2 · Drug: LFX453 L2 · Drug: Placebo 1 · Drug: Placebo 2
once daily: LFX453 cream 1 / LFX453 cream 2
Drug: LFX453 H1 · Drug: LFX453 L1 · Drug: LFX453 H2 · Drug: LFX453 L2
once daily: imiquimod cream
Drug: Imiquimod
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
Drug: LFX453 H1 · Drug: LFX453 L1 · Drug: LFX453 H2 · Drug: LFX453 L2 · Drug: Placebo 1 · Drug: Placebo 2
LFX453 high dose cream 1
LFX453 low dose cream 1
LFX453 high dose cream 2
LFX453 low dose cream 2
Imiquimod cream
Placebo cream 1
Placebo cream 2
General safety (number of subjects with adverse events)
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.
Time frame: 14 days
Local skin tolerability (tolerability score)
Summarized statistics on 5-point scale tolerability scores over 14 days of treatment.
Time frame: 14 days
All parts: Amount (ng/mL) of LFX453 in plasma
Evaluate systemic steady state pharmacokinetics in human after topical administration of LFX453.
Time frame: 14 days
Part 1 and 2: LFX453 concentrations (ng/g) in the skin
LFX453 analyzed in skin.
Time frame: Day 14 and between days 18-21
All parts: LFX453 concentration (ng/mL) in urine
LFX453 analyzed in urine.
Time frame: Day 14
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals