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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes
MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
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.
MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
Placebo matching MK-0517
Aprepitant, oral, tablet, single dose
Aprepitant oral tablet, single dose
Midazolam oral tablet, single dose
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.
Time frame: Up to 72 Hours Post Dose
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