Intervention: NIACIN
Trial phase: Not Applicable
ATC code: C04AC01 | C10AD02 | C10AD52 | C10BA01
SMILES: O=C(O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.
Eligibility criteria:
Inclusion Criteria:

Men and women between the ages of 18 and 75 inclusive
HDL cholesterol >= 25 mg/dL in all subjects, and <= 60 mg/dL in men and <= 70 mg/dL in women
Women must be of non-childbearing potential. They must have been surgically sterilized at least 6 months prior to screening or be postmenopausal. Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion.
Subjects must be in good overall health.
Subjects must be able to comprehend and willing to provide a signed Institutional Regulatory Board (IRB) approved Informed Consent Form.
Subjects must be willing to comply with all study-related procedures.
Subjects must weigh at least 140 pounds to participate in the HDL kinetics Substudy.

Exclusion Criteria:

Clinically-manifest cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
History of diabetes mellitus or fasting glucose > 126 mg/dL at the screening visit
Presence of New York Heart Association (NYHA) Class III or IV chronic heart failure or unstable angina pectoris
History of any other endocrine disease
History of a non-skin malignancy within the previous 5 years
Anemia defined as hemoglobin less than 12 g/dL
Renal insufficiency as defined by creatinine ³ 1.3 mg/dl
Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
Uncontrolled hypertension (Systolic >160 mm Hg and/or Diastolic >100 mmHg on two consecutive measurements
Use of warfarin, or any known coagulopathy and /or elevated Prothrombin time/Partial Thromboplastin Time (PT/PTT) >1.5 x upper limit of normal (ULN)
Self-reported history of Human immunodeficiency virus (HIV) positive
Previous organ transplantation
Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN, or self-reported history of positive for Hepatitis B or Hepatitis C
Any major surgical procedure that occurred within the previous 3 months of the screening visit
History of illicit drug abuse (< 1 year)
Regular use of alcoholic beverages (> 2 drinks/day)
Body mass index (BMI) > 35 kg/m2 or < 18.5 kg/m2
Administration of an investigational drug within 6 weeks prior to the screening visit
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study will be excluded.

Use of daily lipid-altering therapy prior to the initiation of study medication is exclusionary under the following circumstances (washout of non-statins is permitted):

Statins within 4 weeks
Niacin > 250 mg/ day within 6 weeks: Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, or supplemental niacin
Fibrates within 12 weeks: fenofibrate (Antara, Lofibra, Tricor, Triglide), gemfibrozil (Lopid), or clofibrate
Enterically active lipid-altering drugs within 4 weeks: colestipol (Colestid), cholestyramine (Questran), colesevelam (Welchol), ezetimibe (Zetia, Vytorin), orlistat (Xenical, Alli)
Red yeast rice
Fish oil > 2 g/day within 4 weeks: Lovaza (née Omacor), numerous supplements
Altered dose of a selective estrogen receptor modulator (SERM) within 4 weeks
History of severe intolerance of niacin
Men who plan to conceive a child within 3 months of the conclusion of the study.