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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_624 | |||
| MK-0869-165 |
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This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | aprepitant 165 mg |
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| 2 | Active Comparator | aprepitant 185 mg |
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| 3 | Experimental | fosaprepitant 150 mg |
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| 4 | Experimental | aprepitant with food |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant 165 mg | Drug | Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg | Through 72 Hours Postdose | |
| Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg. | Through 72 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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27121336 | Result | Shadle CR, Murphy MG, Liu Y, Ho M, Tatosian D, Li SX, Blum RA. A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects. Clin Pharmacol Drug Dev. 2012 Jul;1(3):93-101. doi: 10.1177/2160763X12447304. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A/B/C/D | Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Comparator: aprepitant 185 mg | Drug | Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3. |
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| Comparator: fosaprepitant 150 mg | Drug | Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3. |
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| Comparator: aprepitant with food | Drug | Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4. |
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| FG001 | B/C/A/D | Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) |
| FG002 | C/A/B/D | Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) |
| FG003 | A/C/B/E | Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state. (The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) |
| FG004 | B/A/C/E | Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state. (The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) |
| FG005 | C/B/A/E | Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state. (The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized patients. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Height | Mean | Full Range | Centimeters |
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| Weight | Mean | Full Range | Kilograms |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg | All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis. | Posted | Mean | Standard Deviation | ng•hr/mL | Through 72 Hours Postdose |
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| Primary | Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg. | All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis. | Posted | Mean | Standard Error | ng/mL | Through 72 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 | 165 mg Aprepitant | 165 mg aprepitant Final Market Composition capsule in the fasted state | 0 | 41 | 12 | 41 | ||
| EG001 | 185 mg Aprepitant | 185 mg aprepitant Final Market Composition capsule in the fasted state | 1 | 42 | 13 | 42 | ||
| EG002 | 150 mg Fosaprepitant Dimeglumine | 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state | 0 | 41 | 15 | 41 | ||
| EG003 | 165 mg Aprepitant (Fed State) | 165 mg aprepitant Final Market Composition capsule in the fed state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) | 0 | 21 | 6 | 21 | ||
| EG004 | 185 mg Aprepitant (Fed State) | 185 mg aprepitant Final Market Composition capsule in the fed state. (The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast) | 0 | 20 | 3 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment | Accidental Overdose reported for 1 subject who inadvertently received 5 capsules of 185 mg aprepitant (925 mg) instead of the protocol prescribed 1 capsule. The subject was discontinued from the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Movement Disorder | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Infusion Site Erythema | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Infusion Site Induration | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Infusion Site Mass | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Puncture Site Indurations | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Procedureal Dizziness | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oropharyngial Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vein Pain | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D005502 | Food |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| two one-sided tests | The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR>0.80 and GMR≥1.25 vs. GMR<1.25). | <0.001 | Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels | Least-Squares Mean Ratio | 1.05 | 2-Sided | 95 | 0.96 | 1.15 | Yes | Non-Inferiority or Equivalence | Equivalence Bounds of (0.80, 1.25). |
| The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects | Least-Squares Mean Ratio | 1.47 | 2-Sided | 90 | 1.23 | 1.76 | No | Superiority or Other |
| The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects | Least-Squares Mean Ratio | 1.08 | 2-Sided | 90 | 0.88 | 1.32 | No | Superiority or Other |
| The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects | Least-Squares Mean Ratio | 1.22 | 2-Sided | 90 | 1.01 | 1.46 | No | Superiority or Other |
| The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects | Least-Squares Mean Ratio | 1.43 | 2-Sided | 90 | 1.16 | 1.75 | No | Superiority or Other |
| OG004 | 185 mg Aprepitant (Light) | 185 mg aprepitant Final Market Composition capsule in the fed state. (The subjects (9) in this treatment group received a standard light breakfast.) |
| OG005 | 185 mg Aprepitant (High-Fat) | 185 mg aprepitant Final Market Composition capsule in the fed state. (The (12) subjects in this treatment group received a standard high-fat breakfast.) |
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