Clinical trial NCT00990821
Conditions: Chemotherapy-Induced Nausea and Vomiting Postoperative Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-01-01; Completion date: 2006-01-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: 100 mg MK-0517 (nonpolysorbate 80 formulation \[non-PS80\]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant arm 2: 100 mg MK-0517 (PS80 formulation \[PS80\]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant arm 3: 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant arm 4: 2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam arm 5: 125 mg aprepitant → 90 mg MK-0517 (PS80) arm 6: 40 mg MK-0517 (non-PS80) → 125 mg aprepitant arm 7: 40 mg MK-0517 (non-PS80) arm 8: 40 mg MK-0517 (non-PS80 formulation) arm 9: 125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) arm 10: 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant arm 11: 115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) arm 12: 125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) arm 13: 100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) arm 14: 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
Interventions: intervention 1: 90 mg MK-0517 (PS80) intervention 2: 100 mg MK-0517 (PS80) intervention 3: 100 MK-0517 (PS80) + 2 mg midazolam intervention 4: 115 mg MK-0517 (PS80) intervention 5: 150 mg MK-0517 (PS80) intervention 6: 40 mg MK-0517 (non-PS80) intervention 7: 100 mg MK-0517 (non-PS80) intervention 8: 150 mg MK-0517 (Non-PS80) intervention 9: Placebo intervention 10: 40 mg Aprepitant intervention 11: 125 mg Aprepitant intervention 12: 2 mg Midazolam
Intervention descriptions: intervention 1: MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes intervention 2: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 3: 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. intervention 4: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 5: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 6: MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. intervention 7: MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. intervention 8: MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. intervention 9: Placebo matching MK-0517 intervention 10: Aprepitant, oral, tablet, single dose intervention 11: Aprepitant oral tablet, single dose intervention 12: Midazolam oral tablet, single dose

Protocol documents: