Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
This study has been completed.
Pharmena North America
Information provided by (Responsible Party):
First received: March 8, 2013
Last updated: August 21, 2013
Last verified: August 2013
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.
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
||A Single-Dose, Randomized, Open-Label, Crossover, Comparative Bioavailability Study of TRIA-662 500 mg Immediate-Release Tablets and NIASPAN 1000 mg Extended-Release Tablets in Healthy Male and Female Volunteers Under Fed Conditions
Primary Outcome Measures:
- ANOVA and 90% Confidence Intervals on ln-transformed, baseline corrected molar urine recovery data of niacin metabolites. [ Time Frame: 96 hours of urine collection ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Peak plasma concentration (Cmax)of each niacin metabolite [ Time Frame: Pre-dose and at 1, 2, 3, 5, 6, 12, 16, 20, 24 and 30 hours after dosing in each study period. ] [ Designated as safety issue: No ]
- Plasma area under the curve to the last measureable timepoint, AUCt [ Time Frame: Pre-dose and at 1, 2, 3, 5, 6, 12, 16, 20, 24 and 30 hours after dosing in each study period. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Active Comparator: Niaspan
Single dose of one NIASPAN® 1000 mg Extended-Release Tablet following dinner
- Extended-release nicotinic acid
- Extended-release niacin
Single dose of two TRIA-662, 500 mg Immediate-Release Tablets following dinner
- 1-methynicotinamide chloride
- N-methylnicotinamide chloride
- MNA chloride
- 1-MNA chloride
|Ages Eligible for Study:
||35 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Main Inclusion Criteria
- Healthy, non-smoking (for at least 6 months prior to drug administration), male and female volunteers, 35-65 years of age, inclusive.
- Body weight within 30% of ideal body weight.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Principal Investigator/Sub-Investigator.
- Systolic blood pressure between 100-140 mmHg, inclusive, and diastolic blood pressure between 60-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the Principal Investigator/Sub-Investigator.
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:
- Alcohol abuse or dependence within one year prior to drug administration.
- Drug abuse or dependence.
- Hypersensitivity or idiosyncratic reaction to niacin, its excipients (e.g. methyl cellulose, povidone, stearic acid), and/or related substances (e.g. nicotinamide [Vit. B3]).
- Hypertension requiring treatment
- Active peptic ulcer
- Hypo or hyperthyroidism not treated or not stable for at least 6 months
- Food allergies and/or presence of any dietary restrictions.
- Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809301
|Bio Pharma Services Inc. (BPSI)
|Toronto, Ontario, Canada, M9L 3A2 |
Pharmena North America
||Eugenio A Cefali, PharmD, PhD.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 8, 2013
||August 21, 2013
||Canada: Health Canada
Keywords provided by Cortria Corporation:
ClinicalTrials.gov processed this record on March 26, 2015