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

NCT01809301 | Completed Phase 1

• 1 other identifier: BPSI-1479
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (1)

• ANOVA and 90% Confidence Intervals on ln-transformed, baseline corrected molar urine recovery data of niacin metabolites.

  96 hours of urine collection

Secondary Outcomes (2)

• 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.

Study Arms (2)

Niaspan

ACTIVE COMPARATOR

Single dose of one NIASPAN® 1000 mg Extended-Release Tablet following dinner

Drug: Niaspan

TRIA-662

EXPERIMENTAL

Single dose of two TRIA-662, 500 mg Immediate-Release Tablets following dinner

Drug: TRIA-662

Interventions

Niaspan DRUG

Also known as: Extended-release nicotinic acid, Extended-release niacin

Niaspan

TRIA-662 DRUG

Also known as: 1-methynicotinamide chloride, N-methylnicotinamide chloride, MNA chloride, 1-MNA chloride

TRIA-662

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Gout
• 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).

Sponsors & Collaborators

• Cortria Corporation: lead
• PPD Development, LP: collaborator
• Pharmena North America: collaborator

Study Sites (1)

Bio Pharma Services Inc. (BPSI)

Toronto, Ontario, M9L 3A2, Canada

Location

MeSH Terms

Interventions

Niacin; N(1)-methylnicotinamide

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Eugenio A Cefali, PharmD, PhD.

  Cortria Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 12, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

CA (1)