DyslipidemiaPhase 1NCT00944645

MK0524A Bioequivalence Study (0524A-059)

A Phase 1 study testing niacin (+) laropiprant (Source 1) and Comparator: niacin (+) laropiprant (Source 2) 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 the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources. 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?: niacin (+) laropiprant (Source 1) and Comparator: niacin (+) laropiprant (Source 2)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 188 participants
Where: No sites listed yet
Study dates: Oct 2006to Jan 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 willing to follow all study guidelines

Who cannot join

Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

About this study

Official title: An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets

This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Conditions: Dyslipidemia
Being tested: niacin (+) laropiprant (Source 1), Comparator: niacin (+) laropiprant (Source 2)
Medical subject headings: Dyslipidemias

What participants receive

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

niacin (+) laropiprant (Source 1)Drug
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
Comparator: niacin (+) laropiprant (Source 2)Drug
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.

Study groups in NCT00944645
Study group	Role	What they receive
A	Active comparator	MK0524A Source 1 (Phase III manufacturing site) Receives: Drug: niacin (+) laropiprant (Source 1)
B	Active comparator	MK0524A Source 2 (commercial manufacturing site) Receives: Drug: Comparator: niacin (+) laropiprant (Source 2)

What is being measured

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

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
Measure of rate of absorption of ER niacin
Measured: Predose and up to 24 hours postdose
Total Amount of Urinary Excretion of Niacin and Its Metabolites
Measure of extent of absorption of ER niacin
Measured: Predose and up to 96 hours postdose
Area Under Curve (AUC 0-infinity) of Laropiprant
Measure of extent of absorption of laropiprant
Measured: Predose and up to 48 hours postdose
Maximum Concentration (Cmax) of Laropiprant
Measure of rate of absorption of laropiprant
Measured: Predose and up to 48 hours postdose

Timeline

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

Oct 2006Jan 2007

First posted23 Jul 2009 (estimated)
Study startOct 2006
Primary completionJan 2007
Study completionJan 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: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00944645
Sponsor's protocol ID: 0524A-059
Other IDs: MK0524A-059, 2009_613
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, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets
ClinicalTrials.gov ID: NCT00944645
Acronym / sponsor ID: 0524A-059
Conditions: Dyslipidemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Jan 2007 (actual)
Study completion: Jan 2007 (actual)
First posted: 23 Jul 2009 (estimated)
Results: Posted 25 Nov 2009

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 definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Study design

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

Arm	Type	Receives
A	Active comparator	Drug: niacin (+) laropiprant (Source 1)MK0524A Source 1 (Phase III manufacturing site)
B	Active comparator	Drug: Comparator: niacin (+) laropiprant (Source 2)MK0524A Source 2 (commercial manufacturing site)

Who may qualify

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

Key inclusion criteria (2 listed)

Subject is in good health
Subject is willing to follow all study guidelines

Key exclusion criteria (1 listed)

Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

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
niacin (+) laropiprant (Source 1)Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.	Drug	A
Comparator: niacin (+) laropiprant (Source 2)Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.	Drug	B

Primary outcome

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
Time frame: Predose and up to 24 hours postdose
Measure of rate of absorption of ER niacin
Total Amount of Urinary Excretion of Niacin and Its Metabolites
Time frame: Predose and up to 96 hours postdose
Measure of extent of absorption of ER niacin
Area Under Curve (AUC 0-infinity) of Laropiprant
Time frame: Predose and up to 48 hours postdose
Measure of extent of absorption of laropiprant
Maximum Concentration (Cmax) of Laropiprant
Time frame: Predose and up to 48 hours postdose
Measure of rate of absorption of laropiprant

Results and safety

Results posted to the registry on 25 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0524A Phase III Tablet Then MK0524A New Site Tablet	94	94
MK0524A New Site Tablet Then MK0524A Phase III Tablet	94	94

Primary outcome: Maximum Plasma Concentration (Cmax) of Nicotinuric Acid

Time frame: Predose and up to 24 hours postdose. Median (Inter-Quartile Range). Unit: ng/mL

Measure	MK0524A New Site Tablet n = 145	MK0524A Phase III Tablet n = 145
Value	1190 (956 to 1610)	1260 (948 to 1660)

MK0524A New Site Tablet vs MK0524A Phase III Tablet: Geometric Mean Ratio: 0.98 (90% CI 0.93 to 1.03)

Population analysed: The Hodges-Lehmann estimator was used to analyze nicotinuric acid Cmax and uses only subjects with data available on both treatment periods. 188 subjects were randomized,17 subjects discontinued, 26 subjects were inadvertently overdosed with 5 tablets of MK0524A 1000 mg/20 mg, reducing the available subject population for analysis to 145.

Primary outcome: Total Amount of Urinary Excretion of Niacin and Its Metabolites

Time frame: Predose and up to 96 hours postdose. Median (Standard Deviation). Unit: micro mole

Measure	MK0524A New Site Tablet n = 157	MK0524A Phase III Tablet n = 161
Value	5280 (1894)	5470 (1330)

MK0524A New Site Tablet vs MK0524A Phase III Tablet: Geometric Mean Ratio: 0.94 (90% CI 0.89 to 0.98)

Population analysed: A linear mixed effect model was used to analyze total amount of urinary excretion of niacin and its metabolite and uses data available from at least one treatment period. 157 subjects had data from the treatment of MK0524A New Site Tablet, and 161 subjects had data from the treatment of MK0524A Phase III Tablet

Primary outcome: Area Under Curve (AUC 0-infinity) of Laropiprant

Time frame: Predose and up to 48 hours postdose. Median (Standard Deviation). Unit: Micro Molar times Hour

Measure	MK0524A New Site Tablet n = 166	MK0524A Phase III Tablet n = 167
Value	6.36 (3.01)	6.37 (2.66)

MK0524A New Site Tablet vs MK0524A Phase III Tablet: Geometric Mean Ratio: 1.00 (95% CI 0.95 to 1.05)

Population analysed: A linear mixed effect model was used to analyze laropiprant AUC0-infinity and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet

Primary outcome: Maximum Concentration (Cmax) of Laropiprant

Time frame: Predose and up to 48 hours postdose. Median (Standard Deviation). Unit: micro Molar

Measure	MK0524A New Site Tablet n = 166	MK0524A Phase III Tablet n = 167
Value	0.988 (0.563)	0.975 (0.466)

MK0524A New Site Tablet vs MK0524A Phase III Tablet: Geometric Mean Ratio: 1.02 (95% CI 0.96 to 1.09)

Population analysed: A linear mixed effect model was used to analyze laropiprant Cmax and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0524A Phase III Tablet	0 of 188 (0%)	98 of 188 (52.1%)	Not reported
MK0524A New Site Tablet	2 of 188 (1.1%)	100 of 188 (53.2%)	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 niacin (+) laropiprant (Source 1) and Comparator: niacin (+) laropiprant (Source 2) 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 2 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 25 Nov 2009). 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?

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid (time frame: Predose and up to 24 hours postdose). The study lists 4 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 NCT00944645.

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.