A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Comparator: ER niacin (+) laropiprant; Comparator: ER niacin; Comparator: laropiprant; Comparator: placebo
Intervention description: ER niacin 2 g/ laropiprant 40 mg daily for 7 days.; ER niacin 2 g daily for 7 days.; laropiprant 40 mg 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
      specific metabolite (which is 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 has a history of T2DM either treated with diet and exercise alone or with
             metformin or a sulfonylurea

          -  Subject is judged to be in good health (other than history of Type 2 diabetes
             mellitus) 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

          -  Subject has a history of stroke, chronic seizures, or major neurological disorder

          -  Subject has a history of clinically significant endocrine (except for Type 2 diabetes
             mellitus), 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 blood or platelet related disorder including prior deep
             venous thrombosis. Subject is being treated with coumadin, heparin, clopidogrel or 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 (with the
             exception of metformin or sulfonylurea agents), including prescription and
             nonprescription drugs or herbal remedies beginning approximately 2 weeks until the
             post-study visit. No concomitant medications may be taken during the study

          -  Subject consumes excessive amounts of alcohol, defined as greater than 3 glasses of
             alcoholic beverages, per day

          -  Subject consumes excessive amounts, defined as greater than 6, 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 uses insulin, PPAR gamma agonists (rosiglitazone or pioglitazone), exenatide
             (Byetta), acarbose (Prandase, Precose) or dipeptidyl-peptidase 4 (DPP-4) inhibitors
             (JANUVIA™1)