MK0524B Bioequivalence Study (0524B-070)

An Open-Label, Definitive Bioequivalence Study to Compare the Pharmacokinetics of the Simvastatin, Nicotinic Acid, and MK0524 (Laropiprant) Components of a Formulation of MK0524B With That of Zocor™ and MK0524A Tablets

This study will evaluate:

1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin); Drug: MK0524A (ER niacin + laropiprant); Drug: Simvastatin

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is in good health
• Subject is a nonsmoker
• Subject is willing to follow the study guidelines

Exclusion Criteria:

• Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MK0524B then Simvastatin + MK0524A; Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.	Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin); Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.; Other Names: MK0524B; Drug: MK0524A (ER niacin + laropiprant); Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.; Other Names: MK0524A; Drug: Simvastatin; Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.; Other Names: Zocor™
EXPERIMENTAL: Simvastatin + MK0524A then MK0524B; Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).	Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin); Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.; Other Names: MK0524B; Drug: MK0524A (ER niacin + laropiprant); Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.; Other Names: MK0524A; Drug: Simvastatin; Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.; Other Names: Zocor™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid	Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin	Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Simvastatin Acid	Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin	48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin	Plasma Area Under the Curve of simvastatin	Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Simvastatin		48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant	Plasma Area Under the Curve of Laropiprant	48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Laropiprant		48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Nicotinuric Acid	Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin	24 Hours Post Dose
Total Urinary Excretion of Niacin and Its Metabolites		96 Hours Post Dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): August 1, 2007
• Study Completion (ACTUAL): August 1, 2007

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (ESTIMATE): July 22, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 19, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Vitamins; Vitamin B Complex; Nicotinic Acids; Simvastatin; Niacinamide; Niacin
• Other Study ID Numbers: 0524B-070; MK0524B-070; 2009_612