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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
| Pharmena North America | INDUSTRY |
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The objective of this study is to compare the absorption of a niacin metabolite (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used to adjust the top dose of a planned TRIA-622 efficacy study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niaspan | Active Comparator | Single dose of one NIASPAN® 1000 mg Extended-Release Tablet following dinner |
|
| TRIA-662 | Experimental | Single dose of two TRIA-662, 500 mg Immediate-Release Tablets following dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niaspan | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| ANOVA and 90% Confidence Intervals on ln-transformed, baseline corrected molar urine recovery data of niacin metabolites. | 96 hours of urine collection |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax)of each niacin metabolite | Pre-dose and at 1, 2, 3, 5, 6, 12, 16, 20, 24 and 30 hours after dosing in each study period. | |
| Plasma area under the curve to the last measureable timepoint, AUCt | Pre-dose and at 1, 2, 3, 5, 6, 12, 16, 20, 24 and 30 hours after dosing in each study period. |
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Main Inclusion Criteria
Main Exclusion Criteria
Known history or presence of any clinically significant hepatic (e.g. active liver disease, hepatic necrosis, jaundice, hepatobiliary disease, hepatic dysfunction), renal/genitourinary (e.g. renal impairment, renal dysfunction), gastrointestinal, cardiovascular (e.g. angina, myocardial infarction), cerebrovascular, pulmonary, endocrine (e.g. diabetes, hypophosphatemia,), immunological, musculoskeletal (e.g. rhabdomyolysis, myopathy), neurological, psychiatric, dermatological or hematological or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first drug administration, as determined by the Principal Investigator/Sub-Investigator.
Known presence of active bleeding.
Known history or presence of:
Intolerance to and/or difficulty with blood sampling through venipuncture.
Use of any prescription medication within 30 days prior to drug administration (except for hormonal contraceptives).
Use of any over-the-counter medications or vitamins (including herbal and/or dietary supplements and/or teas) within 14 days prior to drug administration (except for spermicidal/barrier contraceptive products).
Use of any statins (e.g. lovastatin, simvastatin), bile acid sequestrants (e.g. cholestyramine), aspirin, antihypertensive therapy, vasoactive drugs (e.g. nitrates), calcium channel blockers, adrenergic blocking agents, anticoagulants and vitamins (e.g. multivitamins) within 30 days prior to drug administration.
Women who are pregnant, planning to become pregnant during the study or are nursing.
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| Name | Affiliation | Role |
|---|---|---|
| Eugenio A Cefali, PharmD, PhD. | Cortria Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio Pharma Services Inc. (BPSI) | Toronto | Ontario | M9L 3A2 | Canada |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| C024058 | N(1)-methylnicotinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| TRIA-662 |
| Drug |
|
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |