Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02052687 | A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453 | PHASE1 | COMPLETED | 41 | — | — | Jan 1, 2014 | Jun 1, 2014 | May 15, 2015 | 1 | United Kingdom |
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.
Summarized statistics on 5-point scale tolerability scores over 14 days of treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1: LFX453/placebo | EXPERIMENTAL | 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 |
| Part 2 groupA: LFX453/placebo | EXPERIMENTAL | once daily: LFX453 cream 1 / Placebo 1 |
| Part 2 groupB: LFX453/placebo | EXPERIMENTAL | once daily: LFX453 cream 2 / Placebo 2 |
| Part 2 groupC: LFX453/LFX453 | EXPERIMENTAL | once daily: LFX453 cream 1 / LFX453 cream 2 |
| Part 2 groupD: Imiquimod | OTHER | once daily: imiquimod cream |
| Part 3: LFX453/placebo | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| LFX453 H1 | DRUG | LFX453 high dose cream 1 |
| LFX453 L1 | DRUG | LFX453 low dose cream 1 |
| LFX453 H2 | DRUG | LFX453 high dose cream 2 |
| LFX453 L2 | DRUG | LFX453 low dose cream 2 |
| Imiquimod | DRUG | Imiquimod cream |
| Placebo 1 | DRUG | Placebo cream 1 |
| Placebo 2 | DRUG | Placebo cream 2 |
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 screeni...