Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LTG-321 · 1 trial · 1 indication
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Change from baseline at various individual time points and at various intervals for time to reach pain detection threshold (PDT) and time to reach pain tolerance threshold (PTT), for each dose of LTG-321 vs. placebo.
Assessment of the effect of a high-fat meal on systemic exposure of LTG-321 following a single oral dose administered under fed and fasted conditions.
| Arm | Type | Description |
|---|---|---|
| LTG-321 | EXPERIMENTAL | receives active investigational drug |
| Placebo | PLACEBO_COMPARATOR | receives placebo comparator |
| Name | Type | Description |
|---|---|---|
| LTG-321 | DRUG | active investigational drug |
| Placebo | OTHER | Placebo-to-match LTG-321 |
Inclusion Criteria: * Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent. * Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in ...