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This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) and Pharmacodynamics of orally administered LTG-305 in healthy male and female participants. The study will also include a randomized, double-blind, placebo-controlled within-participant crossover evaluation of pain tolerance during a cold pressor test in healthy male participants 18-55 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTG-305 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTG-305 | Drug | Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants. | Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) | Up to 7 or 10 days of dosing |
| To evaluate the pharmacodynamics of LTG-305 in healthy male participants. | Change from baseline at various individual time points and at various intervals for time to reach PDT and time to reach PTT, for each dose of LTG-305 vs. placebo. Time to reach PDT and time to reach PTT at various individual time points and at various intervals for each dose of LTG-305 vs. placebo. Area above the Curve (AAC) calculated via NPRS scores vs. time, for each dose of LTG-305 vs. placebo Exposure response | 0-24 hrs, 1-12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit | Christchurch | New Zealand |
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