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The primary objective of the study is to assess the blood profile of the N-methylnicotinamide (MNA) following administration of TRIA-662 (N-methylnicotinamide Chloride). The secondary objectives of the study are to characterize the safety and tolerability of TRIA-662 and to assess any potential gender-related differences in the plasma profile of MNA. Changes in serum lipid parameters with particular reference to triglycerides, lipoprotein lipase, and blood pressure effects will also be noted.
A total of 20 subjects volunteers (10 male and 10 female) will receive the following treatments administered in a randomized fashion with 2 embedded placebo dosages in each group (8 active Males and 8 active females with 2 placebo males and females):
The pharmacokinetic and safety assessments will be performed at specified times prior to and after study MNA administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRIA-662 Placebo | Placebo Comparator | Single dose of nine placebo capsules matching TRIA-662 drug capsules |
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| TRIA-662 Low Dose | Experimental | Single-dose of TRIA-662 administered as three 30 mg TRIA-662 capsules and six matching placebo capsules |
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| TRIA-662 High Dose | Experimental | Single dose of TRIA-662 administered as nine 30mg TRIA-662 capsules |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIA-662 | Drug | 1-MNA Chloride |
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| Measure | Description | Time Frame |
|---|---|---|
| MNA Maximum plasma concentration (Cmax). | 5 mL venous blood samples will be collected by venipuncture at the specified times. These blood samples will be properly processed and analyzed for concentration of MNA and metabolites. The concentration data will undergo typical pharmacokinetic data analysis to arrive at the primary endpoints. | 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose. |
| Time to plasma MNA Cmax | 5 mL venous blood samples will be collected by venipuncture at the specified times. These blood samples will be properly processed and analyzed for concentration of MNA and metabolites. The concentration data will undergo typical pharmacokinetic data analysis to arrive at the primary endpoints. | 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose. |
| Area under the plasma MNA concentration curve | 5 mL venous blood samples will be collected by venipuncture at the specified times. These blood samples will be properly processed and analyzed for concentration of MNA and metabolites. The concentration data will undergo typical pharmacokinetic data analysis to arrive at the primary endpoints. | 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Drug | Double-blind placebo |
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