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This is a single-center, open-label, part-randomized, crossover study in 14 healthy participants to assess the PK and safety profile of an SDD formulation of LTG-001 and two crystalline LTG-001 Instant Release tablet formulations, one of which will also be assessed at a differing dose level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 Regimen A SDD Tablet | Experimental |
| |
| Period 2 Regimen B | Experimental |
| |
| Period 3 Regimen C | Experimental |
| |
| Period 4 Regimen D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTG-001 SDD | Drug | LTG-001 |
| |
| LTG-001 Formulation A Prototype 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state. | results of LTG001 peak plasma concentration (Cmax) | From enrollment to Period 4, Day 3 Discharge |
| Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state | Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-last)) | from enrollment to Period 4, Day 3 discharge |
| Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state. | Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-inf)) | from enrollment to Period 4, Day 3 discharge |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state. | Results of Cmax | From Enrollment to Period 4, Day 3 discharge |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state | Results of Tmax | From enrollment to period 4, Day 3 Discharge |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objective | To assess safety and tolerability of single doses of LTG-001 when administered as IR formulations by evaluating number of participants with adverse events and SAEs, with abnormal laboratory tests results, abnormal 12-lead ECG readings, abnormal vital sign measurements and abnormal physical examination findings | from enrollment to Follow up phone call |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences - Miami, Inc | Miami | Florida | 33126 | United States |
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| Drug |
LTG-001 |
|
| LTG-001 Formulation B Prototype 2 | Drug | LTG-001 |
|
| LTG-001 Formulation B prototype 2 | Drug | LTG-001 High Dose |
|
Results of AUC(0-last) |
| enrollment to Period 4, Day 3 discharge |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state. | Results of AUC (0-inf) | from enrollment to Period 4, Day 3 discharge |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state. | Results of T1/2 | from enrollment to Period 4, Day 3 discharge |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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