A Phase 1 interventional study of TRIA-662 and Placebo in Healthy, sponsored by Cortria Corporation. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-26.
Sponsored by Cortria Corporation · Phase 1 and Interventional
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.
Cortria Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of nine placebo capsules matching TRIA-662 drug capsules
Drug: Placebo
Single-dose of TRIA-662 administered as three 30 mg TRIA-662 capsules and six matching placebo capsules
Drug: TRIA-662
Single dose of TRIA-662 administered as nine 30mg TRIA-662 capsules
Drug: TRIA-662
1-MNA Chloride
Also known as: 1-MNA Chloride
Double-blind placebo
Also known as: Dummy
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.
Time frame: 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.
Time frame: 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.
Time frame: 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Cortria Corporation