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
About this trial
This is an interventional treatment trial for Skin Diseases, Bacterial
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
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
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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