Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00990821 | A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012) | PHASE1 | COMPLETED | 188 | — | — | Jan 1, 2005 | Jan 1, 2006 | Aug 19, 2015 | - | — |
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Subject is neither grossly overweight nor underweight for his/her height and body build * Subject is in good health -Subject is a nonsmoker * Subject is willing to avoid excessive alcohol consumption for the duration of the study * Subject is willing to avoid strenuous physica...