Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

This study has been completed.
Sponsor:
Collaborators:
PPD
Pharmena North America
Information provided by (Responsible Party):
Cortria Corporation
ClinicalTrials.gov Identifier:
NCT01809301
First received: March 8, 2013
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Niaspan
Drug: TRIA-662
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cortria Corporation:

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 ]

Enrollment: 20
Study Start Date: March 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Niaspan
Single dose of one NIASPAN® 1000 mg Extended-Release Tablet following dinner
Drug: Niaspan
Other Names:
  • Extended-release nicotinic acid
  • Extended-release niacin
Experimental: TRIA-662
Single dose of two TRIA-662, 500 mg Immediate-Release Tablets following dinner
Drug: TRIA-662
Other Names:
  • 1-methynicotinamide chloride
  • N-methylnicotinamide chloride
  • MNA chloride
  • 1-MNA chloride

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria

  1. Healthy, non-smoking (for at least 6 months prior to drug administration), male and female volunteers, 35-65 years of age, inclusive.
  2. Body weight within 30% of ideal body weight.
  3. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Principal Investigator/Sub-Investigator.
  4. 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

  1. 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.
  2. 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.
  3. Known presence of active bleeding.
  4. 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
    • Gout
    • Food allergies and/or presence of any dietary restrictions.
    • Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
  5. Intolerance to and/or difficulty with blood sampling through venipuncture.
  6. Use of any prescription medication within 30 days prior to drug administration (except for hormonal contraceptives).
  7. 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).
  8. 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.
  9. Women who are pregnant, planning to become pregnant during the study or are nursing.
  Contacts and Locations
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

Locations
Canada, Ontario
Bio Pharma Services Inc. (BPSI)
Toronto, Ontario, Canada, M9L 3A2
Sponsors and Collaborators
Cortria Corporation
PPD
Pharmena North America
Investigators
Study Chair: Eugenio A Cefali, PharmD, PhD. Cortria Corporation
  More Information

No publications provided

Responsible Party: Cortria Corporation
ClinicalTrials.gov Identifier: NCT01809301     History of Changes
Other Study ID Numbers: BPSI-1479
Study First Received: March 8, 2013
Last Updated: August 21, 2013
Health Authority: Canada: Health Canada

Keywords provided by Cortria Corporation:
Bioavailability

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014