Hypercholesterolemia, FamilialPhase 1NCT01583647
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
A Phase 1 study testing MK-0524A in people with Hypercholesterolemia, Familial and Heterozygous Familial Hypercholesterolemia, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
- What is being tested?
- MK-0524A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2012
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia
- Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug
- Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg
- Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.
Who cannot join
- History of psychiatric or personality disorders that may affect the patient's ability to participate
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)
- Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus
- History of neoplastic disease within previous 5 years
- Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)
Show all 12Show fewer
- Has had major surgery, donated and/or received blood within previous 8 weeks
- Participated in another investigational study within previous 4 weeks
- History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Cannot swallow large tablets
- Pregnant or breastfeeding
About this study
Official title: A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.
- Being tested
- MK-0524A
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0524ADrug
Also called Extended-release (ER) Niacin/Laropiprant
1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally
MK-0524ADrug
Also called Extended-release (ER) Niacin/Laropiprant
2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
| Study group | Role | What they receive |
|---|---|---|
| MK-0524A 1 g/20 mg (Panel A) | Experimental | Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg Receives: Drug: MK-0524A |
| MK-0524A 2 g/40 mg (Panel B) | Experimental | Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg Receives: Drug: MK-0524A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
Measured: Predose Day 1 up to 24 hours postdose
Plasma Maximum Concentration (Cmax) of Laropiprant
Measured: Predose on Day 1 up to 48 hours postdose
Total Urinary Excretion of Niacin and Niacin Metabolites
Measured: Predose on Day 1 up to 72 hours postdose
Plasma Cmax of Nicotinuric Acid (NUA)
Measured: Predose on Day 1 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.
- First posted24 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs.
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 Hypercholesterolemia, FamilialStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583647
- Sponsor's protocol ID
- 0524A-158
- Other IDs
- 2012-001443-49
- Status last verified
- Nov 2015
- First submitted
- 20 Apr 2012
- Last updated
- 3 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01583647
- Acronym / sponsor ID
- 0524A-158
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 4 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-0524A 1 g/20 mg (Panel A) | Experimental | Drug: MK-0524ASingle oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg |
| MK-0524A 2 g/40 mg (Panel B) | Experimental | Drug: MK-0524ASingle oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia
- Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug
- Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg
- Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.
Key exclusion criteria (12 listed)
- History of psychiatric or personality disorders that may affect the patient's ability to participate
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)
- Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus
- History of neoplastic disease within previous 5 years
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 |
|---|---|---|
| MK-0524AAlso: Extended-release (ER) Niacin/Laropiprant1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally | Drug | MK-0524A 1 g/20 mg (Panel A) |
| MK-0524AAlso: Extended-release (ER) Niacin/Laropiprant2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally | Drug | MK-0524A 2 g/40 mg (Panel B) |
Primary outcome
Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
Time frame: Predose Day 1 up to 24 hours postdose
Plasma Maximum Concentration (Cmax) of Laropiprant
Time frame: Predose on Day 1 up to 48 hours postdose
Total Urinary Excretion of Niacin and Niacin Metabolites
Time frame: Predose on Day 1 up to 72 hours postdose
Plasma Cmax of Nicotinuric Acid (NUA)
Time frame: Predose on Day 1 up to 48 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-0524A in people with Hypercholesterolemia, Familial and Heterozygous Familial Hypercholesterolemia, 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Nov 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 4 Dec 2013). 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 Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant (time frame: Predose Day 1 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?
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 3 Nov 2015.