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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) of orally or intravenously administered LTG-001 in healthy male and female participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTG-001 | Experimental | Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts |
|
| Placebo | Placebo Comparator | Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTG-001 | Drug | Oral doses |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects | Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) | Up to 10 days of dosing |
| Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration | Absolute bioavailability of LTG-001 will be assessed by comparing systemic exposure following a single oral tablet dose and a single intravenous dose. | from admission to completion in the study (35 days) |
| Safety and Tolerability of Intravenous LTG-001 | Safety and tolerability of intravenous LTG-001 will be assessed by the number of participants with treatment-emergent adverse events (TEAEs), changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), physical examination findings, and infusion site reactions following intravenous administration. | From first intravenous dose through end of study (up to 14 days following intravenous dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| To further characterize the PK of LTG-001 in healthy participants | Cmax | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Area under the concentration curve from 0 to last (AUC0-last) |
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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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| Drug |
Oral doses |
|
| Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Area under the concentration curve from 0 to infinity (AUC0-inf) | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Time of the maximum observed plasma concentration (tmax) | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Elimination rate constant (λz) | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Terminal elimination half-life (t1⁄2) | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Concentration at 12 hours (C12) | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Oral clearance (CL/F) | Up to 10 days of dosing |
| To further characterize the PK of LTG-001 in healthy participants | Oral apparent volume of distribution (Vz/F) | Up to 10 days of dosing |