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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
90 mg MK-0517 (PS80)
100 mg MK-0517 (PS80)
100 MK-0517 (PS80) + 2 mg midazolam
115 mg MK-0517 (PS80)
150 mg MK-0517 (PS80)
40 mg MK-0517 (non-PS80)
100 mg MK-0517 (non-PS80)
150 mg MK-0517 (Non-PS80)
Placebo
40 mg Aprepitant
125 mg Aprepitant
2 mg Midazolam
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part I, Panel A

    Part I, Panel B

    Part I, Panel C

    Part II

    Part III, Panel 1, Treatment Sequence 1

    Part III, Panel 1, Treatment Sequence 2

    Part III, Panel 2

    Part IV

    Part V, Treatment Sequence 1

    Part V, Treatment Sequence 2

    Part V, Treatment Sequence 3

    Part V, Treatment Sequence 4

    Part V, Treatment Sequence 5

    Part V, Treatment Sequence 6

    Arm Description

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

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

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

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

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

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

    40 mg MK-0517 (non-PS80)

    40 mg MK-0517 (non-PS80 formulation)

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

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2009
    Last Updated
    August 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00990821
    Brief Title
    A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
    Official Title
    A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    188 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part I, Panel A
    Arm Type
    Experimental
    Arm Description
    100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant
    Arm Title
    Part I, Panel B
    Arm Type
    Experimental
    Arm Description
    100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
    Arm Title
    Part I, Panel C
    Arm Type
    Experimental
    Arm Description
    40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
    Arm Title
    Part II
    Arm Type
    Experimental
    Arm Description
    2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
    Arm Title
    Part III, Panel 1, Treatment Sequence 1
    Arm Type
    Experimental
    Arm Description
    125 mg aprepitant → 90 mg MK-0517 (PS80)
    Arm Title
    Part III, Panel 1, Treatment Sequence 2
    Arm Type
    Experimental
    Arm Description
    40 mg MK-0517 (non-PS80) → 125 mg aprepitant
    Arm Title
    Part III, Panel 2
    Arm Type
    Experimental
    Arm Description
    40 mg MK-0517 (non-PS80)
    Arm Title
    Part IV
    Arm Type
    Experimental
    Arm Description
    40 mg MK-0517 (non-PS80 formulation)
    Arm Title
    Part V, Treatment Sequence 1
    Arm Type
    Experimental
    Arm Description
    125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
    Arm Title
    Part V, Treatment Sequence 2
    Arm Type
    Experimental
    Arm Description
    100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
    Arm Title
    Part V, Treatment Sequence 3
    Arm Type
    Experimental
    Arm Description
    115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
    Arm Title
    Part V, Treatment Sequence 4
    Arm Type
    Experimental
    Arm Description
    125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
    Arm Title
    Part V, Treatment Sequence 5
    Arm Type
    Experimental
    Arm Description
    100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
    Arm Title
    Part V, Treatment Sequence 6
    Arm Type
    Experimental
    Arm Description
    115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
    Intervention Type
    Drug
    Intervention Name(s)
    90 mg MK-0517 (PS80)
    Intervention Description
    MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    100 mg MK-0517 (PS80)
    Intervention Description
    MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    100 MK-0517 (PS80) + 2 mg midazolam
    Intervention Description
    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
    Intervention Name(s)
    115 mg MK-0517 (PS80)
    Intervention Description
    MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    150 mg MK-0517 (PS80)
    Intervention Description
    MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    40 mg MK-0517 (non-PS80)
    Intervention Description
    MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
    Intervention Type
    Drug
    Intervention Name(s)
    100 mg MK-0517 (non-PS80)
    Intervention Description
    MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
    Intervention Type
    Drug
    Intervention Name(s)
    150 mg MK-0517 (Non-PS80)
    Intervention Description
    MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matching MK-0517
    Intervention Type
    Drug
    Intervention Name(s)
    40 mg Aprepitant
    Intervention Description
    Aprepitant, oral, tablet, single dose
    Intervention Type
    Drug
    Intervention Name(s)
    125 mg Aprepitant
    Intervention Description
    Aprepitant oral tablet, single dose
    Intervention Type
    Drug
    Intervention Name(s)
    2 mg Midazolam
    Intervention Description
    Midazolam oral tablet, single dose
    Primary Outcome Measure Information:
    Title
    Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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