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A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)

Primary Purpose

Skin Diseases, Bacterial

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
midazolam
rosuvastatin
tedizolid phosphate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Bacterial

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy, adult males or females (women of non-childbearing potential)
  • continuous non-smokers who have not used nicotine-containing products for the previous 3 months

Exclusion Criteria:

  • mentally or legally incapacitated or has significant emotional problems
  • history or presence of clinically significant medical or psychiatric condition or disease
  • history or presence of alcoholism or drug abuse within the past 2 years
  • female participants who are pregnant, lactating, or of childbearing potential
  • donated blood or had significant blood loss within 56 days prior to first dose of study drug
  • plasma donation within 7 days prior to first dose of study drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental Arm

    Arm Description

    Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg)

    Outcomes

    Primary Outcome Measures

    Area under the concentration versus time curve, from 0 to last observed/measured non-zero concentration (AUC0-t) of midazolam alone or in combination with tedizolid phosphate
    AUC0-t of rosuvastatin alone or in combination with tedizolid phosphate
    Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of midazolam alone or in combination with tedizolid phosphate
    AUC0-inf of rosuvastatin alone or in combination with tedizolid phosphate
    Maximum observed plasma concentration (Cmax) of midazolam alone or in combination with tedizolid phosphate
    Cmax of rosuvastatin alone or in combination with tedizolid phosphate

    Secondary Outcome Measures

    Full Information

    First Posted
    June 17, 2015
    Last Updated
    August 21, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02477514
    Brief Title
    A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)
    Official Title
    A Multiple-Dose Study to Evaluate the Effects of Steady-State Tedizolid Phosphate Administration on the Pharmacokinetics and Safety of a Single Dose of Midazolam and Rosuvastatin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Diseases, Bacterial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Arm
    Arm Type
    Experimental
    Arm Description
    Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    midazolam
    Intervention Description
    2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14
    Intervention Type
    Drug
    Intervention Name(s)
    rosuvastatin
    Intervention Description
    10 mg tablet administered as a single oral dose on Days 3 and 16
    Intervention Type
    Drug
    Intervention Name(s)
    tedizolid phosphate
    Intervention Description
    200 mg oral tablet administered once daily on Days 5-17
    Primary Outcome Measure Information:
    Title
    Area under the concentration versus time curve, from 0 to last observed/measured non-zero concentration (AUC0-t) of midazolam alone or in combination with tedizolid phosphate
    Time Frame
    Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
    Title
    AUC0-t of rosuvastatin alone or in combination with tedizolid phosphate
    Time Frame
    Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
    Title
    Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of midazolam alone or in combination with tedizolid phosphate
    Time Frame
    Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
    Title
    AUC0-inf of rosuvastatin alone or in combination with tedizolid phosphate
    Time Frame
    Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
    Title
    Maximum observed plasma concentration (Cmax) of midazolam alone or in combination with tedizolid phosphate
    Time Frame
    Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
    Title
    Cmax of rosuvastatin alone or in combination with tedizolid phosphate
    Time Frame
    Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy, adult males or females (women of non-childbearing potential) continuous non-smokers who have not used nicotine-containing products for the previous 3 months Exclusion Criteria: mentally or legally incapacitated or has significant emotional problems history or presence of clinically significant medical or psychiatric condition or disease history or presence of alcoholism or drug abuse within the past 2 years female participants who are pregnant, lactating, or of childbearing potential donated blood or had significant blood loss within 56 days prior to first dose of study drug plasma donation within 7 days prior to first dose of study drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)

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