NCT00943124

Brief Summary

This study will evaluate:

  1. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 6, 2010

Completed
Last Updated

June 19, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

July 21, 2009

Results QC Date

October 9, 2009

Last Update Submit

May 22, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

MK0524B then Simvastatin + MK0524A

EXPERIMENTAL

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)Drug: MK0524A (ER niacin + laropiprant)Drug: Simvastatin

Simvastatin + MK0524A then MK0524B

EXPERIMENTAL

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)Drug: MK0524A (ER niacin + laropiprant)Drug: Simvastatin

Interventions

MK0524B (ER niacin (+) laropiprant (+) simvastatin)DRUG

Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.

Also known as: MK0524B
MK0524B then Simvastatin + MK0524ASimvastatin + MK0524A then MK0524B
MK0524A (ER niacin + laropiprant)DRUG

Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.

Also known as: MK0524A
MK0524B then Simvastatin + MK0524ASimvastatin + MK0524A then MK0524B
SimvastatinDRUG

Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Also known as: Zocor™
MK0524B then Simvastatin + MK0524ASimvastatin + MK0524A then MK0524B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

MK-0524Simvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 22, 2009

Study Start

July 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

June 19, 2015

Results First Posted

January 6, 2010

Record last verified: 2015-05