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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chemotherapy-Induced Nausea and Vomiting Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part I, Panel A

100 mg MK-0517 (nonpolysorbate 80 formulation \[non-PS80\]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant

Group Type EXPERIMENTAL

100 MK-0517 (PS80) + 2 mg midazolam

Intervention Type 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.

100 mg MK-0517 (non-PS80)

Intervention Type DRUG

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

150 mg MK-0517 (Non-PS80)

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo matching MK-0517

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part I, Panel B

100 mg MK-0517 (PS80 formulation \[PS80\]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

150 mg MK-0517 (PS80)

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo matching MK-0517

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part I, Panel C

40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant

Group Type EXPERIMENTAL

40 mg MK-0517 (non-PS80)

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo matching MK-0517

40 mg Aprepitant

Intervention Type DRUG

Aprepitant, oral, tablet, single dose

Part II

2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

2 mg Midazolam

Intervention Type DRUG

Midazolam oral tablet, single dose

Part III, Panel 1, Treatment Sequence 1

125 mg aprepitant → 90 mg MK-0517 (PS80)

Group Type EXPERIMENTAL

90 mg MK-0517 (PS80)

Intervention Type DRUG

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

40 mg MK-0517 (non-PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part III, Panel 1, Treatment Sequence 2

40 mg MK-0517 (non-PS80) → 125 mg aprepitant

Group Type EXPERIMENTAL

40 mg MK-0517 (non-PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part III, Panel 2

40 mg MK-0517 (non-PS80)

Group Type EXPERIMENTAL

40 mg MK-0517 (non-PS80)

Intervention Type DRUG

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

Part IV

40 mg MK-0517 (non-PS80 formulation)

Group Type EXPERIMENTAL

40 mg MK-0517 (non-PS80)

Intervention Type DRUG

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

Part V, Treatment Sequence 1

125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

115 mg MK-0517 (PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part V, Treatment Sequence 2

100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

115 mg MK-0517 (PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part V, Treatment Sequence 3

115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

115 mg MK-0517 (PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part V, Treatment Sequence 4

125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

115 mg MK-0517 (PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part V, Treatment Sequence 5

100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

115 mg MK-0517 (PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Part V, Treatment Sequence 6

115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant

Group Type EXPERIMENTAL

100 mg MK-0517 (PS80)

Intervention Type DRUG

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

115 mg MK-0517 (PS80)

Intervention Type DRUG

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

125 mg Aprepitant

Intervention Type DRUG

Aprepitant oral tablet, single dose

Interventions

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90 mg MK-0517 (PS80)

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

Intervention Type DRUG

100 mg MK-0517 (PS80)

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

Intervention Type 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.

Intervention Type DRUG

115 mg MK-0517 (PS80)

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

Intervention Type DRUG

150 mg MK-0517 (PS80)

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

Intervention Type DRUG

40 mg MK-0517 (non-PS80)

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

Intervention Type DRUG

100 mg MK-0517 (non-PS80)

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

Intervention Type DRUG

150 mg MK-0517 (Non-PS80)

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

Intervention Type DRUG

Placebo

Placebo matching MK-0517

Intervention Type DRUG

40 mg Aprepitant

Aprepitant, oral, tablet, single dose

Intervention Type DRUG

125 mg Aprepitant

Aprepitant oral tablet, single dose

Intervention Type DRUG

2 mg Midazolam

Midazolam oral tablet, single dose

Intervention Type DRUG

Eligibility Criteria

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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 physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
* Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

Exclusion Criteria

* Subject has a history of multiple and/or severe allergies to drugs or food
* Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
* Subject has an infection, including Human immunodeficiency virus (HIV) infection
* Subject is a regular user of any illicit drug
* Subject consumes excessive amounts of alcohol
* Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
* Subject currently uses on a regular basis, any prescription or non prescription medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes