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

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ClinicalTrials.gov Identifier: NCT01809301
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : August 22, 2013
Sponsor:
Collaborators:
PPD
Pharmena North America
Information provided by (Responsible Party):
Cortria Corporation

Tracking Information
First Submitted Date  ICMJE March 8, 2013
First Posted Date  ICMJE March 12, 2013
Last Update Posted Date August 22, 2013
Study Start Date  ICMJE March 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
ANOVA and 90% Confidence Intervals on ln-transformed, baseline corrected molar urine recovery data of niacin metabolites. [ Time Frame: 96 hours of urine collection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Niaspan
    Other Names:
    • Extended-release nicotinic acid
    • Extended-release niacin
  • Drug: TRIA-662
    Other Names:
    • 1-methynicotinamide chloride
    • N-methylnicotinamide chloride
    • MNA chloride
    • 1-MNA chloride
Study Arms  ICMJE
  • Active Comparator: Niaspan
    Single dose of one NIASPAN® 1000 mg Extended-Release Tablet following dinner
    Intervention: Drug: Niaspan
  • Experimental: TRIA-662
    Single dose of two TRIA-662, 500 mg Immediate-Release Tablets following dinner
    Intervention: Drug: TRIA-662
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809301
Other Study ID Numbers  ICMJE BPSI-1479
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cortria Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cortria Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • PPD
  • Pharmena North America
Investigators  ICMJE
Study Chair: Eugenio A Cefali, PharmD, PhD. Cortria Corporation
PRS Account Cortria Corporation
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP