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Also known as Fosaprepitant, Fosaprepitant dimeglumine, EMEND® for Injection, Experimental: fosaprepitant, Emend injection
MK-0517 · 2 trials · 3 indications
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
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.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 40 mg MK0517 IV |
| 2 | ACTIVE_COMPARATOR | 4 mg ondansetron IV |
| 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 |
| Part I, Panel B | EXPERIMENTAL | 100 mg MK-0517 (PS80 formulation \[PS80\]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant |
| Part I, Panel C | EXPERIMENTAL | 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant |
| Part II | EXPERIMENTAL | 2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam |
| Part III, Panel 1, Treatment Sequence 1 | EXPERIMENTAL | 125 mg aprepitant → 90 mg MK-0517 (PS80) |
| Part III, Panel 1, Treatment Sequence 2 | EXPERIMENTAL | 40 mg MK-0517 (non-PS80) → 125 mg aprepitant |
| Part III, Panel 2 | EXPERIMENTAL | 40 mg MK-0517 (non-PS80) |
| Part IV | EXPERIMENTAL | 40 mg MK-0517 (non-PS80 formulation) |
| Part V, Treatment Sequence 1 | EXPERIMENTAL | 125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) |
| Part V, Treatment Sequence 2 | EXPERIMENTAL | 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant |
| Part V, Treatment Sequence 3 | EXPERIMENTAL | 115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) |
| Part V, Treatment Sequence 4 | EXPERIMENTAL | 125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) |
| Part V, Treatment Sequence 5 | EXPERIMENTAL | 100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) |
| Part V, Treatment Sequence 6 | EXPERIMENTAL | 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant |
| Name | Type | Description |
|---|---|---|
| Comparator: MK0517 | DRUG | a single administration of 40 mg MK0517 by IV immediately prior to surgery |
| Comparator: ondansetron | DRUG | a single administration of 4 mg ondansetron by IV immediately prior to surgery |
| 90 mg MK-0517 (PS80) | DRUG | MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes |
| 100 mg MK-0517 (PS80) | DRUG | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
| 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. |
| 115 mg MK-0517 (PS80) | DRUG | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
| 150 mg MK-0517 (PS80) | DRUG | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
| 40 mg MK-0517 (non-PS80) | DRUG | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
| 100 mg MK-0517 (non-PS80) | DRUG | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
| 150 mg MK-0517 (Non-PS80) | DRUG | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
| Placebo | DRUG | Placebo matching MK-0517 |
| 40 mg Aprepitant | DRUG | Aprepitant, oral, tablet, single dose |
| 125 mg Aprepitant | DRUG | Aprepitant oral tablet, single dose |
| 2 mg Midazolam | DRUG | Midazolam oral tablet, single dose |
Inclusion Criteria: * Open abdominal surgery requiring 24 hour hospital stay * General anesthesia * Post-operative opioids * ASA status of I-III Exclusion Criteria: * Patient exhibits evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or cardiovascular cond...
MK-0517 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for the prevention of chemotherapy-induced nausea and vomiting and post-operative nausea and vomiting. It has been studied in controlled, double-blind clinical trials, including one Phase 1 study in healthy subjects and one Phase 3 study in patients.
MK-0517 is being studied for the prevention of chemotherapy-induced nausea and vomiting and post-operative nausea and vomiting. Clinical trials have enrolled adults 18 years and older, including healthy volunteers in an early tolerability study and surgical patients at risk of post-operative nausea and vomiting.
MK-0517 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical studies of the compound, including the Phase 1 tolerability study MK-0517-012 and the Phase 3 study 0517-015 in post-operative nausea and vomiting.
MK-0517 is an investigational drug that has been studied in Phase 1 and Phase 3 clinical trials. It is not described as approved, and its development status is best characterized as clinical stage, with the completed trials including a Phase 1 study in healthy subjects and a Phase 3 study in patients.
MK-0517 has been evaluated in two completed trials: NCT00990821, a Phase 1 study of safety and tolerability in healthy subjects that enrolled 188 participants, and NCT00231777, a Phase 3 study for the prevention of post-operative nausea and vomiting that enrolled 216 participants. Both were controlled and double-blind.