A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Comparator: niacin + laropiprant; Comparator: niacin; Comparator: laropiprant; Comparator: placebo
Intervention description: ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days; ER niacin 2 g tablet once daily for 7 days; laropiprant 40 mg once daily for 7 days; matching placebo tablets for each of the interventions once daily for 7 days
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER
      niacin, laropiprant, and placebo over the course of seven days on urinary levels of a
      metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects may not be pregnant and/or will agree to use appropriate method of
             contraception beginning at least 2 weeks prior to administration of the first dose of
             study drug in the first treatment period, throughout the study and until at least 2
             weeks after administration of the last dose of study drug in the last treatment
             period.

          -  Subject is judged to be in good health based on medical history, physical examination,
             vital sign measurements, and laboratory safety tests performed at the prestudy
             (screening) visit and/or prior to administration of the initial dose of study drug.

          -  Subject has no clinically significant abnormality on electrocardiogram (ECG) performed
             at the prestudy (screening) visit and/or prior to administration of the initial dose
             of study drug.

          -  Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing
             products for at least approximately 6 months; subjects who have discontinued smoking
             or the use of nicotine/nicotine containing products for at least approximately 3
             months may be enrolled in the study at the discretion of the investigator

        Exclusion Criteria:

          -  Subject is mentally or legally incapacitated, has significant emotional problems at
             the time of prestudy (screening) visit or expected during the conduct of the study or
             has a history of a clinically significant psychiatric disorder over the last 5 to 10
             years. - Subjects who have had situational depression may be enrolled in the study at
             the discretion of the investigator.

          -  Subject has a history of stroke, chronic seizures, or major neurological disorder.

          -  Subject has a history of clinically significant endocrine, gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
             genitourinary abnormalities or diseases.

          -  Subject has a history of neoplastic disease (including leukemia, lymphoma, malignant
             melanoma), or myeloproliferative disease, regardless of the time since treatment.

          -  Subject has history of a thrombotic or platelet related disorder including prior deep
             venous thrombosis. Subject is being treated with coumadin, heparin, clopidogrel has
             used these agents within 2 weeks of screening. Subject is being treated with aspirin
             or has used this agent within 3 weeks prior to administration of screening.

          -  Subject is unable to refrain from or anticipates the use of any medication, including
             prescription and non- prescription drugs or herbal remedies beginning approximately 2
             weeks prior to administration of the initial dose of study drug, throughout the study
             until the poststudy visit.

          -  Subject consumes excessive amounts of alcohol, defined as greater than 3 glasses, of
             alcoholic beverages or distilled spirits per day.

          -  Subject consumes excessive amounts, defined as greater than 6 servings, of coffee,
             tea, cola, or other caffeinated beverages per day.

          -  Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL)
             or participated in another investigational study within 4 weeks prior to the prestudy
             (screening) visit.

          -  Subject has a history of significant multiple and/or severe allergies, or has had an
             anaphylactic reaction or significant intolerability to prescription or
             non-prescription drugs or food.

          -  Subject is currently a regular user of any illicit drugs or has a history of drug
             (including alcohol) abuse within approximately 6 months.