A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)

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.

Conditions

• Chemotherapy-Induced Nausea and Vomiting
• Postoperative Nausea and Vomiting

Interventions

DRUG

90 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes

DRUG

100 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

DRUG

100 MK-0517 (PS80) + 2 mg midazolam

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.

DRUG

115 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

DRUG

150 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

DRUG

40 mg MK-0517 (non-PS80)

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

DRUG

100 mg MK-0517 (non-PS80)

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

DRUG

150 mg MK-0517 (Non-PS80)

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

DRUG

Placebo

Placebo matching MK-0517

DRUG

40 mg Aprepitant

Aprepitant, oral, tablet, single dose

DRUG

125 mg Aprepitant

Aprepitant oral tablet, single dose

DRUG

2 mg Midazolam

Midazolam oral tablet, single dose

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2005-12-31

Completion

2006-01-31