DyslipidemiaPhase 1NCT00943124

MK0524B Bioequivalence Study (0524B-070)

A Phase 1 study testing MK0524B (ER niacin (+) laropiprant (+) simvastatin), MK0524A (ER niacin + laropiprant) and Simvastatin in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dyslipidemia
What is being tested?: MK0524B (ER niacin (+) laropiprant (+) simvastatin), MK0524A (ER niacin + laropiprant) and Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: No sites listed yet
Study dates: Jul 2007to Aug 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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:

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.
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.

Conditions: Dyslipidemia
Being tested: MK0524B (ER niacin (+) laropiprant (+) simvastatin), MK0524A (ER niacin + laropiprant), Simvastatin
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK0524B (ER niacin (+) laropiprant (+) simvastatin)Drug
Also called MK0524B
Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
MK0524A (ER niacin + laropiprant)Drug
Also called MK0524A
Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
SimvastatinDrug
Also called Zocor™
Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Study groups in NCT00943124
Study group	Role	What they receive
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. Receives: 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). Receives: Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin); Drug: MK0524A (ER niacin + laropiprant); Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Simvastatin Acid
Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Measured: 48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
Plasma Area Under the Curve of simvastatin
Measured: Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Simvastatin
Measured: 48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
Plasma Area Under the Curve of Laropiprant
Measured: 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Laropiprant
Measured: 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
Measured: 24 Hours Post Dose
Total Urinary Excretion of Niacin and Its Metabolites
Measured: 96 Hours Post Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Aug 2007

First posted22 Jul 2009 (estimated)
Study startJul 2007
Primary completionAug 2007
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00943124
Sponsor's protocol ID: 0524B-070
Other IDs: MK0524B-070, 2009_612
Status last verified: May 2015
First submitted: 21 Jul 2009
Last updated: 19 Jun 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy

All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00943124
Acronym / sponsor ID: 0524B-070
Conditions: Dyslipidemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Aug 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 22 Jul 2009 (estimated)
Results: Posted 6 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate:

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.
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MK0524B then Simvastatin + MK0524A	Experimental	Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin), Drug: MK0524A (ER niacin + laropiprant), Drug: SimvastatinPeriod 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.
Simvastatin + MK0524A then MK0524B	Experimental	Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin), Drug: MK0524A (ER niacin + laropiprant), Drug: SimvastatinPeriod 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).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK0524B (ER niacin (+) laropiprant (+) simvastatin)Also: MK0524BSingle dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.	Drug	MK0524B then Simvastatin + MK0524A, Simvastatin + MK0524A then MK0524B
MK0524A (ER niacin + laropiprant)Also: MK0524ASingle dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.	Drug	MK0524B then Simvastatin + MK0524A, Simvastatin + MK0524A then MK0524B
SimvastatinAlso: Zocor™Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.	Drug	MK0524B then Simvastatin + MK0524A, Simvastatin + MK0524A then MK0524B

Primary outcome

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

Results and safety

Results posted to the registry on 6 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0524B Then Simvastatin + MK0524A	110	108
Simvastatin + MK0524A Then MK0524B	110	108

Primary outcome: Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid

Time frame: Through 48 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng/mL * Hour

Measure	MK0524B n = 200	Simvastatin + MK0524A n = 202
Value	9.19 (8.38)	8.03 (7.78)

MK0524B vs Simvastatin + MK0524A: Least-Squares Mean Ratio: 1.14 (90% CI 1.09 to 1.20)

Population analysed: Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 200 and 202 subjects were available for simvastatin acid AUC(0 to 48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.

Primary outcome: Peak Plasma Concentration (Cmax) of Simvastatin Acid

Time frame: 48 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng/mL

Measure	MK0524B n = 201	Simvastatin + MK0524A n = 202
Value	1.016 (0.946)	0.918 (0.906)

MK0524B vs Simvastatin + MK0524A: Least-Squares Mean Ratio: 1.11 (90% CI 1.05 to 1.16)

Population analysed: Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 201 and 202 subjects were available for simvastatin acid Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.

Primary outcome: Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin

Time frame: Through 48 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng/mL * Hour

Measure	MK0524B n = 208	Simvastatin + MK0524A n = 210
Value	15.03 (9.88)	15.56 (9.11)

MK0524B vs Simvastatin + MK0524A: Least-Squares Mean Ratio: 0.97 (90% CI 0.93 to 1.00)

Population analysed: Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 208 and 210 subjects were available for simvastatin AUC(0-48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.

Primary outcome: Peak Plasma Concentration (Cmax) of Simvastatin

Time frame: 48 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng/mL

Measure	MK0524B n = 209	Simvastatin + MK0524A n = 210
Value	5.81 (4.31)	6.33 (4.64)

MK0524B vs Simvastatin + MK0524A: Least-Squares Mean Ratio: 0.92 (90% CI 0.87 to 0.97)

Population analysed: Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 209 and 210 subjects were available for simvastatin Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0524B	0 of 220 (0%)	61 of 220 (27.7%)	Not reported
Simvastatin + MK0524A	0 of 220 (0%)	58 of 220 (26.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dyslipidemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK0524B (ER niacin (+) laropiprant (+) simvastatin), MK0524A (ER niacin + laropiprant) and Simvastatin in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid (time frame: Through 48 Hours Post Dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00943124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.