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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001443-49 | EudraCT Number |
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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0524A | Drug | 1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant | Predose Day 1 up to 24 hours postdose | |
| Plasma Maximum Concentration (Cmax) of Laropiprant | Predose on Day 1 up to 48 hours postdose | |
| Total Urinary Excretion of Niacin and Niacin Metabolites | Predose on Day 1 up to 72 hours postdose | |
| Plasma Cmax of Nicotinuric Acid (NUA) | Predose on Day 1 up to 48 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042;NCT00461630) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-0524A 1 g/20 mg (Panel A) | Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg |
| FG001 | MK-0524A 2 g/40 mg (Panel B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MK-0524A | Drug | 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally |
|
|
Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0524A 1 g/20 mg (Panel A) | Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant | The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted. | Posted | Predose Day 1 up to 24 hours postdose |
|
| |||||||||||||||||||||||
| Primary | Plasma Maximum Concentration (Cmax) of Laropiprant | The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted. | Posted | Predose on Day 1 up to 48 hours postdose |
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| |||||||||||||||||||||||
| Primary | Total Urinary Excretion of Niacin and Niacin Metabolites | The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted. | Posted | Predose on Day 1 up to 72 hours postdose |
|
| |||||||||||||||||||||||
| Primary | Plasma Cmax of Nicotinuric Acid (NUA) | The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted. | Posted | Predose on Day 1 up to 48 hours postdose |
|
|
up to 14 days for each panel
MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-0524A 1 g/20 mg (Panel A) | Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg | 0 | 10 | 7 | 10 | ||
| EG001 | MK-0524A 2 g/40 mg (Panel B) | Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Bruising of arm | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Diuresis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Facial flushing | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| C518174 | MK-0524 |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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