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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Skin Diseases, Bacterial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm

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)

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14

rosuvastatin

Intervention Type DRUG

10 mg tablet administered as a single oral dose on Days 3 and 16

tedizolid phosphate

Intervention Type DRUG

200 mg oral tablet administered once daily on Days 5-17

Interventions

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midazolam

2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14

Intervention Type DRUG

rosuvastatin

10 mg tablet administered as a single oral dose on Days 3 and 16

Intervention Type DRUG

tedizolid phosphate

200 mg oral tablet administered once daily on Days 5-17

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes