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| ID | Type | Description | Link |
|---|---|---|---|
| MK0524A-059 | |||
| 2009_613 |
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This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | MK0524A Source 1 (Phase III manufacturing site) |
|
| B | Active Comparator | MK0524A Source 2 (commercial manufacturing site) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niacin (+) laropiprant (Source 1) | Drug | Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Nicotinuric Acid | Measure of rate of absorption of ER niacin | 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 | Predose and up to 96 hours postdose |
| Area Under Curve (AUC 0-infinity) of Laropiprant | Measure of extent of absorption of laropiprant | Predose and up to 48 hours postdose |
| Maximum Concentration (Cmax) of Laropiprant | Measure of rate of absorption of laropiprant | Predose and up to 48 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0524A Phase III Tablet Then MK0524A New Site Tablet | MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)/MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2) |
| FG001 | MK0524A New Site Tablet Then MK0524A Phase III Tablet | MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)/ MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Includes all participants from Both treatment groups; MK0524A Phase III tablet and MK0524A New Site tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Plasma Concentration (Cmax) of Nicotinuric Acid | Measure of rate of absorption of ER niacin | 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. | Posted | Median | Inter-Quartile Range | ng/mL | Predose and up to 24 hours postdose |
|
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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 | MK0524A Phase III Tablet | MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematemesis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| 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 |
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| 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. |
|
| NOT COMPLETED |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Full Range | Centimeters |
|
| Weight | Mean | Full Range | Kilograms |
|
MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
|
|
|
| Primary | Total Amount of Urinary Excretion of Niacin and Its Metabolites | Measure of extent of absorption of ER niacin | 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 | Posted | Median | Standard Deviation | micro mole | Predose and up to 96 hours postdose |
|
|
|
|
| Primary | Area Under Curve (AUC 0-infinity) of Laropiprant | Measure of extent of absorption of laropiprant | 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 | Posted | Median | Standard Deviation | Micro Molar times Hour | Predose and up to 48 hours postdose |
|
|
|
|
| Primary | Maximum Concentration (Cmax) of Laropiprant | Measure of rate of absorption of laropiprant | 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. | Posted | Median | Standard Deviation | micro Molar | Predose and up to 48 hours postdose |
|
|
|
|
| 0 |
| 188 |
| 98 |
| 188 |
| EG001 | MK0524A New Site Tablet | MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2) | 2 | 188 | 100 | 188 |
| Syncope | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Ear Discomfort | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Defaecation Urgency | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Epigastric Discomfort | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Herpes Simplex | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Blood Amylase Increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Haemoglobin Decreased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Helicobacter Pylori Identification Test Positive | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Lipase Increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Occult Blood Positive | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Bladder Pain | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Vasodilatation | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006573 |
| Heterocyclic Compounds, 1-Ring |