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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0517-012 |
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This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I, Panel A | Experimental | 100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant |
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| Part I, Panel B | Experimental | 100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant |
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| Part I, Panel C | Experimental | 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant |
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| Part II | Experimental | 2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam |
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| Part III, Panel 1, Treatment Sequence 1 | Experimental | 125 mg aprepitant → 90 mg MK-0517 (PS80) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90 mg MK-0517 (PS80) | Drug | MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V | AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms. | Up to 72 Hours Post Dose |
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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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One Investigator in the United States. Primary therapy period: 31-Jan-2005 to 01-Dec-2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I, Panel A | 100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant |
| FG001 | Part I, Panel B | 100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Part III, Panel 1, Treatment Sequence 2 | Experimental | 40 mg MK-0517 (non-PS80) → 125 mg aprepitant |
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| Part III, Panel 2 | Experimental | 40 mg MK-0517 (non-PS80) |
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| Part IV | Experimental | 40 mg MK-0517 (non-PS80 formulation) |
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| Part V, Treatment Sequence 1 | Experimental | 125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) |
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| Part V, Treatment Sequence 2 | Experimental | 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant |
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| Part V, Treatment Sequence 3 | Experimental | 115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) |
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| Part V, Treatment Sequence 4 | Experimental | 125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) |
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| Part V, Treatment Sequence 5 | Experimental | 100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) |
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| Part V, Treatment Sequence 6 | Experimental | 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant |
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| 100 mg MK-0517 (PS80) | Drug | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
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| 100 MK-0517 (PS80) + 2 mg midazolam | Drug | MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517. |
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| 115 mg MK-0517 (PS80) | Drug | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
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| 150 mg MK-0517 (PS80) | Drug | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
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| 40 mg MK-0517 (non-PS80) | Drug | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
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| 100 mg MK-0517 (non-PS80) | Drug | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
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| 150 mg MK-0517 (Non-PS80) | Drug | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
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| Placebo | Drug | Placebo matching MK-0517 |
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| 40 mg Aprepitant | Drug | Aprepitant, oral, tablet, single dose |
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| 125 mg Aprepitant | Drug | Aprepitant oral tablet, single dose |
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| 2 mg Midazolam | Drug | Midazolam oral tablet, single dose |
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| FG002 | Part I, Panel C | 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant |
| FG003 | Part II | 2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam |
| FG004 | Part III, Panel 1, Treatment Sequence 1 | 125 mg aprepitant → 90 mg MK-0517 (PS80) |
| FG005 | Part III, Panel 1, Treatment Sequence 2 | 40 mg MK-0517 (non-PS80) → 125 mg aprepitant |
| FG006 | Part III, Panel 2 | 40 mg MK-0517 (non-PS80) |
| FG007 | Part IV | 40 mg MK-0517 (non-PS80 formulation) |
| FG008 | Part V, Treatment Sequence 1 | 125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) |
| FG009 | Part V, Treatment Sequence 2 | 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant |
| FG010 | Part V, Treatment Sequence 3 | 115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) |
| FG011 | Part V, Treatment Sequence 4 | 125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) |
| FG012 | Part V, Treatment Sequence 5 | 100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) |
| FG013 | Part V, Treatment Sequence 6 | 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I, Panel A | 100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant |
| BG001 | Part I, Panel B | 100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant |
| BG002 | Part I, Panel C | 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant |
| BG003 | Part II | 2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam |
| BG004 | Part III, Panel 1, Treatment Sequence 1 | 125 mg aprepitant → 90 mg MK-0517 (PS80) |
| BG005 | Part III, Panel 1, Treatment Sequence 2 | 40 mg MK-0517 (non-PS80) → 125 mg aprepitant |
| BG006 | Part III, Panel 2 | 40 mg MK-0517 (non-PS80) |
| BG007 | Part IV | 40 mg MK-0517 (non-PS80 formulation) |
| BG008 | Part V, Treatment Sequence 1 | 125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) |
| BG009 | Part V, Treatment Sequence 2 | 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant |
| BG010 | Part V, Treatment Sequence 3 | 115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) |
| BG011 | Part V, Treatment Sequence 4 | 125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) |
| BG012 | Part V, Treatment Sequence 5 | 100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) |
| BG013 | Part V, Treatment Sequence 6 | 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant |
| BG014 | Total | Total of all reporting groups |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V | AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms. | All participants in Part V who had at least one period of AUC data were included in the evaluation of pharmacokinetics. Participants without sufficient concentration data for an AUC calculation included: 6 participants in the Aprepitant (125 mg) , 8 participants in the MK-0517 (100 mg) group, and 5 participants in the MK-0517 (115 mg) group. | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | Up to 72 Hours Post Dose |
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Up to 30 days after the last dose of study drug
All 188 study participants are included in the safety population: Adverse events are reported for the actual doses given in any part of the study. Individual participants may have received more than one drug or more than one dose of a drug.
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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 | 90 mg MK-0517 (PS80) | MK-0517, PS80 formulation, administered with a single IV administration | 0 | 31 | 8 | 31 | ||
| EG001 | 100 mg MK-0517 (PS80) | MK-0517, PS80 formulation, administered with a single IV administration | 0 | 82 | 8 | 82 | ||
| EG002 | 100 mg MK-0517 (PS80) + 2 mg Midazolam | PS80 formulation, administered with a single IV administration and a single oral administration of midazolam | 0 | 8 | 5 | 8 | ||
| EG003 | 115 mg MK-0517 (PS80) | MK-0517, PS80 formulation, administered with a single IV administration | 0 | 66 | 7 | 66 | ||
| EG004 | 150 mg MK-0517 (PS80) | MK-0517, PS80 formulation, administered with a single IV administration | 0 | 12 | 3 | 12 | ||
| EG005 | 40 mg MK-0517 (Non-PS80) | MK-0517, non-PS80 formulation, administered with a single IV administration | 0 | 36 | 4 | 36 | ||
| EG006 | 100 mg MK-0517 (Non-PS80) | MK-0517, PS80 formulation, administered with a single IV administration | 0 | 12 | 3 | 12 | ||
| EG007 | 150 mg MK-0517 (Non-PS80) | MK-0517, PS80 formulation, administered with a single IV administration | 0 | 11 | 6 | 11 | ||
| EG008 | Placebo | Placebo matching MK-0517 (PS80 or non-PS80) | 0 | 11 | 2 | 11 | ||
| EG009 | 40 mg Aprepitant | Aprepitant administered by a single oral capsule | 0 | 14 | 2 | 14 | ||
| EG010 | 125 mg Aprepitant | Aprepitant administered as a single oral capsule | 0 | 133 | 6 | 133 | ||
| EG011 | 2 mg Midazolam | Midazolam administered as a single oral solution | 0 | 8 | 2 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration | General disorders | MedDRA (8.1) | Systematic Assessment |
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| Tenderness | General disorders | MedDRA (8.1) | Systematic Assessment |
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| Infusion Site Pain | General disorders | MedDRA (8.1) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
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| Swelling | General disorders | MedDRA (8.1) | Systematic Assessment |
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| Pain | General disorders | MedDRA (8.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
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| Intraocular Pressure Test | Investigations | MedDRA (8.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (8.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA (8.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA (8.1) | 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 |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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