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

Study Overview
=================
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.

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

Conditions
-----------------
Skin Diseases, Bacterial

Intervention / Treatment
-----------------
* Drug: midazolam
* Drug: rosuvastatin
* Drug: tedizolid phosphate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>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) | Drug: midazolam<br>* 2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14<br>Drug: rosuvastatin<br>* 10 mg tablet administered as a single oral dose on Days 3 and 16<br>Drug: tedizolid phosphate<br>* 200 mg oral tablet administered once daily on Days 5-17<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours | 
| AUC0-t of rosuvastatin alone or in combination with tedizolid phosphate |  | Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours | 
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of midazolam alone or in combination with tedizolid phosphate |  | Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours | 
| AUC0-inf of rosuvastatin alone or in combination with tedizolid phosphate |  | Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours | 
| Maximum observed plasma concentration (Cmax) of midazolam alone or in combination with tedizolid phosphate |  | Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours | 
| Cmax of rosuvastatin alone or in combination with tedizolid phosphate |  | Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours |