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This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand.
The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTG-321 | Experimental | receives active investigational drug |
|
| Placebo | Placebo Comparator | receives placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTG-321 | Drug | active investigational drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) of single and multiple ascending oral doses of LTG-321 in healthy participants | Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) | Up to 14 days of dosing |
| To evaluate the Pain Detection and Tolerance Threshold during Cold Pressor Test of LTG-321 in healthy male participants. | 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. | Up to 5 days of dosing |
| Effect of Food on Pharmacokinetics of LTG-321 | 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. | Up to approximately 48 hours post-dose in each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Christchurch | New Zealand |
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| Other |
Placebo-to-match LTG-321 |
|